Trial Outcomes & Findings for Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer (NCT NCT04827732)
NCT ID: NCT04827732
Last Updated: 2025-09-29
Results Overview
* MTD is defined as the dose associated with a 35% probability of dose-limiting toxicity (DLT). * DLT is defined as any toxicity listed below that occurs within 6 months from start of treatment and is considered possibly, probably, or definitely related to proton reirradiation: * Any grade 5 toxicities * Any grade 4-5 GI toxicities * Bowel obstruction * Grade 3-5: diarrhea; anal, colonic, or bowel ulcers; bladder perforation; any fistula formations; peripheral motor/sensory neuropathy of the pelvis above baseline; osteonecrosis/soft tissue necrosis; radiation dermatitis; hematuria; hematochezia; bowel/pelvic hemorrhage; reproductive tract toxicity * Toxicity will be graded using CTCAE v5
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
From start of treatment through 6 months
Results posted on
2025-09-29
Participant Flow
Participant milestones
| Measure |
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
7
|
3
|
4
|
|
Overall Study
COMPLETED
|
1
|
6
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Overall Study
Did not start treatment
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) in Recurrent Rectal Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=7 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=4 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=1 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=99 Participants
|
66 years
n=107 Participants
|
67 years
n=206 Participants
|
54 years
n=7 Participants
|
56 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
1 participants
n=7 Participants
|
15 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From start of treatment through 6 monthsPopulation: 3 participants are not evaluable for this outcome measure. 2 participants did not start treatment. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol.
* MTD is defined as the dose associated with a 35% probability of dose-limiting toxicity (DLT). * DLT is defined as any toxicity listed below that occurs within 6 months from start of treatment and is considered possibly, probably, or definitely related to proton reirradiation: * Any grade 5 toxicities * Any grade 4-5 GI toxicities * Bowel obstruction * Grade 3-5: diarrhea; anal, colonic, or bowel ulcers; bladder perforation; any fistula formations; peripheral motor/sensory neuropathy of the pelvis above baseline; osteonecrosis/soft tissue necrosis; radiation dermatitis; hematuria; hematochezia; bowel/pelvic hemorrhage; reproductive tract toxicity * Toxicity will be graded using CTCAE v5
Outcome measures
| Measure |
All Dose Levels: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=12 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy), dose level 2 (35 Gy), and dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Reirradiation Using Hypofractionated IMPT
|
40 GY in 5 fractions
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 6 weeks to 3 months post-completion of radiation therapy (range 7-14 weeks)Population: 1 participant is not evaluable in Dose Level 1 because they did not start treatment. 1 participant is not evaluable in Dose Level 3 because they did not start treatment. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the patient.
-DRE, endoscopy, and cross-sectional imaging will be used to measure clinical complete response rate
Outcome measures
| Measure |
All Dose Levels: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=6 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy), dose level 2 (35 Gy), and dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Clinical Complete Response Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Through completion of follow-up (full range 1.81 months-13.87 months)Population: 1 participant is not evaluable in Dose Level 1 because they did not start treatment. 1 participant is not evaluable in Dose Level 3 because they did not start treatment. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the patient.
-Defined as time from end of radiation therapy to date of first instance of local or regional tumor progression
Outcome measures
| Measure |
All Dose Levels: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=6 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy), dose level 2 (35 Gy), and dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Median Freedom From Locoregional Progression (FFLP)
|
7.53 months
Interval 1.81 to 13.87
|
9.53 months
Interval 2.01 to 10.72
|
4.37 months
Interval 4.01 to 12.72
|
—
|
SECONDARY outcome
Timeframe: Through completion of follow-up (full range 4.4 months to 13.87 months)Population: 1 participant is not evaluable in Dose Level 1 because they did not start treatment. 1 participant is not evaluable in Dose Level 3 because they did not start treatment. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the patient.
Defined as time from end of radiation therapy to date that at least 50% of patients died
Outcome measures
| Measure |
All Dose Levels: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=6 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy), dose level 2 (35 Gy), and dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Median Overall Survival (OS)
|
NA months
Interval 6.4 to 13.87
Median overall survival not reached as at least 50% of the participants are still alive
|
9.53 months
Interval 8.58 to 10.72
|
NA months
Interval 4.4 to 12.72
Median overall survival not reached as at least 50% of the participants are still alive
|
—
|
SECONDARY outcome
Timeframe: Through completion of follow-up (full range 1.81 months-13.87 months)Population: 1 participant is not evaluable in Dose Level 1 because they did not start treatment. 1 participant is not evaluable in Dose Level 3 because they did not start treatment. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the patient.
-Defined as time from end of radiation therapy to the earliest date of locoregional progression, distant progression, or death from any cause
Outcome measures
| Measure |
All Dose Levels: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=6 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy), dose level 2 (35 Gy), and dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Median Progression-free Survival (PFS)
|
2.04 months
Interval 1.32 to 13.87
|
9.53 months
Interval 2.01 to 10.72
|
4.37 months
Interval 4.01 to 12.72
|
—
|
SECONDARY outcome
Timeframe: Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatmentPopulation: This outcome measure includes data for participants who completed the questionnaire. If a participant did not complete the questionnaire at a specific time point, then the participant is not included in the number analyzed at that time point. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the participant.
30 question survey which assesses patient well-being with 5 functional scales, 9 symptom scales, \& global health scale. Scores for each scale range from 0-100. Higher score for the functional scale \& global health represent high functioning, while high score for symptom scale represents high symptomatology. Median scores were taken for each scale for each dose level and the different between pre-treatment and post-treatment scores were calculated to determine change in score over time. For functional scales and global health status, negative values represent improved functionality/quality of life, while positive values represent diminished functionality. For symptom scales, the opposite is true. If patients did not complete the the survey at each time point, their data was censored. Data values were averaged prior to 3 months. Differences were taken between baseline values and the average value calculated of post-RT up to 3 months.
Outcome measures
| Measure |
All Dose Levels: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=4 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy), dose level 2 (35 Gy), and dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=1 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status
|
-4.17 score on a scale
Interval -25.0 to 16.67
|
0 score on a scale
Interval -33.3 to 16.67
|
8.34 score on a scale
Interval 8.34 to 8.34
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Physical functioning
|
0 score on a scale
Interval 0.0 to 0.0
|
6.67 score on a scale
Interval 0.0 to 13.33
|
-6.67 score on a scale
Interval -6.67 to -6.67
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Role functioning
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
-16.67 score on a scale
Interval -16.67 to -16.67
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Emotional functioning
|
-6.67 score on a scale
Interval -20.0 to 0.0
|
0 score on a scale
Interval -33.33 to 6.67
|
6.67 score on a scale
Interval 6.67 to 6.67
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Cognitive functioning
|
-8.33 score on a scale
Interval -16.67 to 0.0
|
0 score on a scale
Interval -33.3 to 16.67
|
-16.67 score on a scale
Interval -16.67 to -16.67
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Pain
|
0 score on a scale
Interval 0.0 to 0.0
|
-16.67 score on a scale
Interval -16.67 to 33.33
|
16.66 score on a scale
Interval 16.66 to 16.66
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Insomnia
|
0 score on a scale
Interval -33.33 to 33.33
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Appetite loss
|
0 score on a scale
Interval 0.0 to 33.33
|
0 score on a scale
Interval 0.0 to 0.0
|
33.33 score on a scale
Interval 33.33 to 33.33
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Financial difficulties
|
0 score on a scale
Interval 0.0 to 66.67
|
0 score on a scale
Interval -33.33 to 0.0
|
33.33 score on a scale
Interval 33.33 to 33.33
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Dyspnea
|
0 score on a scale
Interval -33.3 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
33.33 score on a scale
Interval 33.33 to 33.33
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Constipation
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Diarrhea
|
16.67 score on a scale
Interval 0.0 to 33.33
|
0 score on a scale
Interval -33.33 to 33.33
|
33.33 score on a scale
Interval 33.33 to 33.33
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning
|
8.33 score on a scale
Interval 0.0 to 50.0
|
0 score on a scale
Interval 0.0 to 0.0
|
-33.33 score on a scale
Interval -33.33 to -33.33
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Fatigue
|
0 score on a scale
Interval -22.2 to 0.0
|
0 score on a scale
Interval -11.11 to 22.22
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Nausea and vomiting
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval -16.67 to 0.0
|
16.67 score on a scale
Interval 16.67 to 16.67
|
—
|
SECONDARY outcome
Timeframe: Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatmentPopulation: This outcome measure includes data for participants who completed the questionnaire. If a participant did not complete the questionnaire at a specific time point, then the participant is not included in the number analyzed at that time point. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the participant.
30 question survey which assesses patient well-being with 5 functional scales, 9 symptom scales, \& global health scale. Scores for each scale range from 0-100. Higher score for the functional scale \& global health represent high functioning, while high score for symptom scale represents high symptomatology. Median scores were taken for each scale for each dose level and the different between pre-treatment and post-treatment scores were calculated to determine change in score over time. For functional scales and global health status, negative values represent improved functionality/quality of life, while positive values represent diminished functionality. For symptom scales, the opposite is true. If patients did not complete the survey at each time point, their data was censored. Data values were averaged from 3-12 months. Differences were taken between baseline values and the average value calculated of post-RT from 3-12 months.
Outcome measures
| Measure |
All Dose Levels: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=4 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy), dose level 2 (35 Gy), and dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=1 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status
|
8.33 score on a scale
Interval 0.0 to 54.17
|
0 score on a scale
Interval -22.22 to 0.0
|
8.33 score on a scale
Interval 8.33 to 8.33
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Physical functioning
|
3.33 score on a scale
Interval 0.0 to 26.67
|
2.22 score on a scale
Interval 0.0 to 3.33
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Role functioning
|
16.67 score on a scale
Interval 0.0 to 58.33
|
11.11 score on a scale
Interval 0.0 to 33.33
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Emotional functioning
|
-3.33 score on a scale
Interval -16.67 to 20.0
|
-2.22 score on a scale
Interval -10.0 to 0.0
|
-10 score on a scale
Interval -10.0 to -10.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Cognitive functioning
|
0 score on a scale
Interval -16.67 to 8.33
|
-8.33 score on a scale
Interval -16.67 to 0.0
|
-8.34 score on a scale
Interval -8.34 to -8.34
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Pain
|
-10.42 score on a scale
Interval -75.0 to 0.0
|
25 score on a scale
Interval -33.33 to 27.78
|
16.66 score on a scale
Interval 16.66 to 16.66
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Dyspnea
|
-16.67 score on a scale
Interval -100.0 to 0.0
|
0 score on a scale
Interval -16.67 to 33.33
|
16.66 score on a scale
Interval 16.66 to 16.66
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Appetite loss
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval -33.33 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Constipation
|
-16.67 score on a scale
Interval -33.33 to 0.0
|
0 score on a scale
Interval -11.11 to 0.0
|
-16.67 score on a scale
Interval -16.67 to -16.67
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Diarrhea
|
0 score on a scale
Interval -16.67 to 0.0
|
0 score on a scale
Interval -50.0 to 33.33
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Social functioning
|
8.33 score on a scale
Interval 0.0 to 16.67
|
5.56 score on a scale
Interval 0.0 to 16.67
|
-25 score on a scale
Interval -25.0 to -25.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Fatigue
|
-19.44 score on a scale
Interval -61.11 to -5.56
|
5.56 score on a scale
Interval 0.0 to 25.93
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Nausea and vomiting
|
0 score on a scale
Interval -8.33 to 0.0
|
0 score on a scale
Interval -5.56 to 8.33
|
-8.33 score on a scale
Interval -8.33 to -8.33
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Insomnia
|
-25 score on a scale
Interval -33.33 to -8.33
|
0 score on a scale
Interval -11.11 to 16.67
|
33.34 score on a scale
Interval 33.34 to 33.34
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Financial difficulties
|
0 score on a scale
Interval -33.33 to 66.67
|
0 score on a scale
Interval 0.0 to 33.33
|
16.67 score on a scale
Interval 16.67 to 16.67
|
—
|
SECONDARY outcome
Timeframe: Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatmentPopulation: This outcome measure includes data for participants who completed the questionnaire. If a participant did not complete the questionnaire at a specific time point, then the participant is not included in the number analyzed at that time point. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the participant.
29 question survey which assesses quality of life for patients with colorectal cancer including functional \& symptom status. The survey includes 4 multi-item scales \& 19 single-item scales. Scores are linearly transformed to provide a score from 0-100. A high score for functional scales represents high level of functioning, while a high score for symptom scale represents high level of symptoms. Median scores were taken for each scale \& the difference between baseline \& varying time points was reported. Negative value represents improved function for a functional scale item, \& worsening symptoms for symptom scale items. Positive values represent the converse. If patients did not complete the survey at each time point, their data was censored. Data values were averaged prior to 3 months. Differences were taken between pre-treatment (baseline) values and the average value calculated of post-RT up to 3 months.
Outcome measures
| Measure |
All Dose Levels: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=4 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy), dose level 2 (35 Gy), and dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=1 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Anxiety
|
0 score on a scale
Interval -33.33 to 33.33
|
0 score on a scale
Interval 0.0 to 0.0
|
-33.34 score on a scale
Interval -33.34 to -33.34
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Body image
|
-12.5 score on a scale
Interval -25.0 to 0.0
|
8.33 score on a scale
Interval -16.67 to 8.33
|
8.34 score on a scale
Interval 8.34 to 8.34
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Stoma related problems
|
11.11 score on a scale
Interval 0.0 to 16.67
|
0 score on a scale
Interval 0.0 to 0.0
|
5.56 score on a scale
Interval 5.56 to 5.56
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Defecation problems
|
0 score on a scale
Interval 0.0 to 16.67
|
0 score on a scale
Interval -16.67 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Embarrassed by bowel movements
|
33.34 score on a scale
Interval 33.34 to 33.34
|
—
|
—
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Male sexual function
|
0 score on a scale
Interval -66.67 to 66.67
|
-16.67 score on a scale
Interval -33.33 to 0.0
|
—
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Female sexual function
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
-33.33 score on a scale
Interval -33.33 to -33.33
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Micturition
|
4.17 score on a scale
Interval -8.33 to 8.33
|
-8.33 score on a scale
Interval -25.0 to 0.0
|
8.33 score on a scale
Interval 8.33 to 8.33
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Abdominal and pelvic pain
|
0 score on a scale
Interval 0.0 to 16.67
|
-16.67 score on a scale
Interval -33.33 to 33.33
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Bloated feeling
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to -3.33
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Dry mouth
|
0 score on a scale
Interval 0.0 to 3.33
|
0 score on a scale
Interval -33.33 to 33.33
|
-33.34 score on a scale
Interval -33.34 to -33.34
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Hair loss
|
0 score on a scale
Interval 0.0 to 66.67
|
0 score on a scale
Interval 0.0 to 0.0
|
-66.67 score on a scale
Interval -66.67 to -66.67
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Trouble with taste
|
0 score on a scale
Interval 0.0 to 0.0
|
-33.3 score on a scale
Interval -66.6 to 0.0
|
33.34 score on a scale
Interval 33.34 to 33.34
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Fecal incontinence
|
16.67 score on a scale
Interval 16.67 to 16.67
|
—
|
—
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Sore skin
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Impotence
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Dyspareunia
|
-33.33 score on a scale
Interval -33.33 to -33.33
|
—
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatmentPopulation: This outcome measure includes data for participants who completed the questionnaire. If a participant did not complete the questionnaire at a specific time point, then the participant is not included in the number analyzed at that time point. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the participant.
29 question survey which assesses quality of life for patients with colorectal cancer including functional \& symptom status. The survey includes 4 multi-item scales \& 19 single-item scales. Scores are linearly transformed to provide a score from 0-100. A high score for functional scales represents high level of functioning, while a high score for symptom scale represents high level of symptoms. Median scores were taken for each scale \& the difference between baseline \& varying time points was reported. Negative value represents improved function for a functional scale item, \& worsening symptoms for symptom scale items. Positive values represent the converse. If patients did not complete the survey at each time point, their data was censored. Data values were averaged from 3-12 months. Differences were taken between baseline values and the average value calculated of post-RT from 3-12 months
Outcome measures
| Measure |
All Dose Levels: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=4 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy), dose level 2 (35 Gy), and dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=1 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Hair loss
|
0 score on a scale
Interval -33.33 to 66.67
|
0 score on a scale
Interval -77.78 to 16.67
|
-33.33 score on a scale
Interval -33.33 to -33.33
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Trouble with taste
|
0 score on a scale
Interval 0.0 to 0.0
|
-33.33 score on a scale
Interval -50.0 to -22.22
|
50 score on a scale
Interval 50.0 to 50.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Defecation problems
|
0 score on a scale
Interval 0.0 to 8.33
|
0 score on a scale
Interval -22.22 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Fecal incontinence
|
16.67 score on a scale
Interval 16.67 to 16.67
|
—
|
—
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Anxiety
|
8.33 score on a scale
Interval -8.33 to 16.67
|
0 score on a scale
Interval 0.0 to 0.0
|
-16.67 score on a scale
Interval -16.67 to -16.67
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Body image
|
1.04 score on a scale
Interval -16.67 to 20.83
|
-8.33 score on a scale
Interval -22.22 to 8.33
|
4.17 score on a scale
Interval 4.17 to 4.17
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Male sexual function
|
0 score on a scale
Interval 0.0 to 0.0
|
-16.67 score on a scale
Interval -33.33 to 0.0
|
—
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Female sexual function
|
8.34 score on a scale
Interval 8.34 to 8.34
|
0 score on a scale
Interval 0.0 to 0.0
|
-33.33 score on a scale
Interval -33.33 to -33.33
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Micturition
|
0 score on a scale
Interval -12.5 to 8.33
|
-19.44 score on a scale
Interval -41.67 to 16.67
|
4.16 score on a scale
Interval 4.16 to 4.16
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Abdominal and pelvic pain
|
-8.33 score on a scale
Interval -75.0 to 0.0
|
0 score on a scale
Interval 0.0 to 22.22
|
-8.33 score on a scale
Interval -8.33 to -8.33
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Bloated feeling
|
0 score on a scale
Interval -33.33 to 0.0
|
0 score on a scale
Interval -33.33 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Dry mouth
|
0 score on a scale
Interval -33.33 to 33.33
|
0 score on a scale
Interval -16.67 to 0.0
|
16.66 score on a scale
Interval 16.66 to 16.66
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Stoma related problems
|
2.78 score on a scale
Interval -8.33 to 13.89
|
-5.56 score on a scale
Interval -11.11 to 0.0
|
5.56 score on a scale
Interval 5.56 to 5.56
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Sore skin
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Embarrassed by bowel movements
|
33.34 score on a scale
Interval 33.34 to 33.34
|
—
|
—
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Impotence
|
0 score on a scale
Interval 0.0 to 0.0
|
-33.3 score on a scale
Interval -33.3 to -33.3
|
—
|
—
|
|
Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29)
Dyspareunia
|
-33.34 score on a scale
Interval -33.34 to -33.34
|
—
|
0 score on a scale
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: From start of treatment through 3 months after completion of radiation therapy (estimated to be 3 months and 1 week)Population: 1 participant is not evaluable in Dose Level 1 because they did not start treatment. 1 participant is not evaluable in Dose Level 3 because they did not start treatment.
Outcome measures
| Measure |
All Dose Levels: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=6 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy), dose level 2 (35 Gy), and dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=1 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Fatigue
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Dyspareunia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Pelvic pressure
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Vaginal dryness
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Erectile dysfunction
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Scrotal pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Urinary urgency
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Urinary retention
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Bladder spasm
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Dysuria
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Diarrhea
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Dehydration
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Nausea
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Constipation
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Small intestinal obstruction
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Rectal bleeding
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0
Buttock pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From 3 month post-completion of radiation therapy to 12 months post-completion of radiation therapyPopulation: 1 participant is not evaluable in Dose Level 1 because they did not start treatment. 1 participant is not evaluable in Dose Level 3 because they did not start treatment. 1 participants in Dose Level -1 is not evaluable as patient did not have follow-up to evaluate for late adverse effects.
Outcome measures
| Measure |
All Dose Levels: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=6 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy), dose level 2 (35 Gy), and dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 Participants
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Rectal pain
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Rectal perforation
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Anemia
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Fatigue
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Urinary tract obstruction
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Urinary incontinence
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Nausea
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Abdominal pain
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Constipation
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Ischemic bowel
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Rectal stump dehiscence
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Stool leakage
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Small intestinal obstruction
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Diarrhea
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Anorexia
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Myalgia
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Back pain
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Pain in extremity
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Generalized weakness
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Muscle ache
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Peripheral neuropathy
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Fall
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Ulceration (ankle)
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Alopecia
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Leaking abscess
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0
Lymphedema
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
Adverse Events
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=1 participants at risk
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=6 participants at risk
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 participants at risk
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 participants at risk
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Ischemic bowel
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Rectal perforation
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
General disorders
Redness and drainage around buttocks wound
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Hepatobiliary disorders
Cholecystitis
|
100.0%
1/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Infections and infestations
Chronic abscess
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Injury, poisoning and procedural complications
Pelvic abscess (complication from surgery)
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to disease progression
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
2/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
66.7%
2/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
Other adverse events
| Measure |
Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=1 participants at risk
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level -1 (25 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=6 participants at risk
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 1 (30 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 participants at risk
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 2 (35 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT)
n=3 participants at risk
* Radiotherapy will consist of five fractions, delivered once daily, with pencil beam scanning proton beam therapy using the defined dose in dose level 3 (40 Gy).
* The use of Intensity Modulated Radiation Therapy (IMRT) with photon beam therapy is permitted at the discretion of the treating investigator in order to avoid extended treatment delays due to logistical reasons (e.g. machine downtime).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Eye disorders
Scleral disorder
|
100.0%
1/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
66.7%
2/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
100.0%
3/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
66.7%
2/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Full feeling
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
100.0%
1/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Mouth sore
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
66.7%
2/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Rectal frequency and urgency
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Stool leakage
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
66.7%
2/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
General disorders
Chills
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
General disorders
Cold sensitivity
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
66.7%
2/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
General disorders
Fatigue
|
100.0%
1/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
2/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
66.7%
2/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
66.7%
2/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
General disorders
Fever
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
General disorders
Pain
|
100.0%
1/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
83.3%
5/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Infections and infestations
COVID-19 infection
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Infections and infestations
Mass or abscess with leaking
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Injury, poisoning and procedural complications
Bruising
|
100.0%
1/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Investigations
Blood lactacte dehydrogenase increased
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
1/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
66.7%
2/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle ache/tightness
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Musculoskeletal and connective tissue disorders
Sciatic pain
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor reopened after radiation
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Nervous system disorders
Peripheral motor neutropathy
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
2/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
2/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Renal and urinary disorders
Urinary hesitancy
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
2/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
50.0%
3/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Reproductive system and breast disorders
Pelvic pressure
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
66.7%
2/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
100.0%
1/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
100.0%
1/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Skin and subcutaneous tissue disorders
Skin tingling
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
16.7%
1/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/1 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/6 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
0.00%
0/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
33.3%
1/3 • All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
|
Additional Information
Dr. Michael Waters
Washington University School of Medicine
Phone: 314-747-7236
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place