Trial Outcomes & Findings for Non-Operative Management and Early Response Assessment in Rectal Cancer (NCT NCT03904043)
NCT ID: NCT03904043
Last Updated: 2026-05-01
Results Overview
\- Criteria for clinical complete response: * No residual gross tumor at procto/sigmoidoscopy; or only erythematous scar or ulcer * No palpable tumor on DRE * No radiographic evidence of tumor on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
Completion of treatment (estimated to be 22 weeks)
Results posted on
2026-05-01
Participant Flow
Participant milestones
| Measure |
Radiation + FOLFOX
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
8
|
|
Overall Study
COMPLETED
|
51
|
7
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Radiation + FOLFOX
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Non-compliance
|
1
|
0
|
|
Overall Study
Did not start chemotherapy
|
1
|
0
|
Baseline Characteristics
Non-Operative Management and Early Response Assessment in Rectal Cancer
Baseline characteristics by cohort
| Measure |
Radiation + FOLFOX
n=55 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=8 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=14 Participants
|
60 years
n=34 Participants
|
61 years
n=69 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=14 Participants
|
2 Participants
n=34 Participants
|
19 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=14 Participants
|
6 Participants
n=34 Participants
|
44 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=14 Participants
|
8 Participants
n=34 Participants
|
63 Participants
n=69 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=14 Participants
|
1 Participants
n=34 Participants
|
7 Participants
n=69 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=14 Participants
|
7 Participants
n=34 Participants
|
56 Participants
n=69 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=14 Participants
|
8 participants
n=34 Participants
|
63 participants
n=69 Participants
|
PRIMARY outcome
Timeframe: Completion of treatment (estimated to be 22 weeks)\- Criteria for clinical complete response: * No residual gross tumor at procto/sigmoidoscopy; or only erythematous scar or ulcer * No palpable tumor on DRE * No radiographic evidence of tumor on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment)
Outcome measures
| Measure |
Radiation + FOLFOX
n=51 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=7 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Clinical Complete Response Rate
|
36 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 2 years* Criteria for progressive disease: * Increase in the size of primary tumor by RECIST criteria (increase of at least 20% from nadir in the sum of the target lesion, with an absolute increase of at least 5 mm) * New metastatic disease * PFS is defined as the time from date of treatment to death or progression, which occurs first. The alive patients without progression are censored as the last date follow-up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment through the completion of treatment (estimated to be 22 weeks)\- The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Outcome measures
| Measure |
Radiation + FOLFOX
n=55 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=8 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Fall
|
1 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Fatigue
|
1 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Febrile neutropenia
|
1 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Hyperglycemia
|
3 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Hypertension
|
1 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Hypoalbuminemia
|
0 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Hypocalcemia
|
0 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Hypokalemia
|
2 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Hyponatremia
|
1 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Infection - cellulitis
|
1 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Neutrophil count decreased
|
22 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Peripheral sensory neuropathy
|
1 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Platelet count decreased
|
0 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Proctitis
|
2 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Rectal hemorrhage
|
1 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Rectal pain
|
0 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Skin infection
|
1 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Superior vena cava syndrome
|
1 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Thromboembolic event
|
1 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Vomiting
|
0 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Weight loss
|
0 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
White blood cell decreased
|
7 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Abdominal pain
|
0 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Acidosis
|
1 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Alanine aminotransferase increased
|
2 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Anal pain
|
0 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Anemia
|
1 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Anorexia
|
0 Participants
|
2 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Anxiety
|
0 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Aspartate aminotransferase increased
|
1 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Congestive heart failure
|
1 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Dehydration
|
1 Participants
|
0 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Delirium
|
0 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Diarrhea
|
5 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Depression
|
0 Participants
|
1 Participants
|
|
Incidence of Any Grade 3 or Higher Toxicity During Treatment
Generalized muscle weakness
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At 1 year after the start of radiation\- The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Outcome measures
| Measure |
Radiation + FOLFOX
n=55 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=8 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Incidence of Post Chemoradiotherapy Grade 3 or Higher Toxicity
|
26 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapyPopulation: One patient in the Radiation + CAPOX was not evaluable for this outcome measure. Participants are not included in the specified time point if they did not complete the questionnaire.
* Physical Well-Being section of the FACT-C questionnaire consists of 7 questions. * Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score for this section ranges from 0-28.
Outcome measures
| Measure |
Radiation + FOLFOX
n=55 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=7 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Physical Well-Being)
Baseline
|
25.27 score on FACT-C scale
Standard Deviation 4.08
|
18.26 score on FACT-C scale
Standard Deviation 7.93
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Physical Well-Being)
Completion of chemo
|
22.97 score on FACT-C scale
Standard Deviation 4.91
|
17.5 score on FACT-C scale
Standard Deviation 6.53
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Physical Well-Being)
10-14 months post radiation therapy
|
23.64 score on FACT-C scale
Standard Deviation 5.08
|
20.33 score on FACT-C scale
Standard Deviation 4.51
|
SECONDARY outcome
Timeframe: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapyPopulation: One patient in the Radiation + CAPOX was not evaluable for this outcome measure. Participants are not included in the specified time point if they did not complete the questionnaire.
* Social/Family Well-Being section of the FACT-C questionnaire consists of 7 questions. * Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score for this section ranges from 0-28.
Outcome measures
| Measure |
Radiation + FOLFOX
n=55 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=7 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Social/Family Well-Being)
Baseline
|
23.87 score on FACT-C scale
Standard Deviation 4.91
|
23.83 score on FACT-C scale
Standard Deviation 6.32
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Social/Family Well-Being)
Completion of chemo
|
24.66 score on FACT-C scale
Standard Deviation 3.42
|
24.14 score on FACT-C scale
Standard Deviation 2.96
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Social/Family Well-Being)
10-14 months post radiation therapy
|
24.65 score on FACT-C scale
Standard Deviation 4.47
|
23.56 score on FACT-C scale
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapyPopulation: One patient in the Radiation + CAPOX and one patient in the Radiation + FOLFOX were not evaluable for this outcome measure. Participants are not included in the specified time point if they did not complete the questionnaire.
* Emotional Well-Being section of the FACT-C questionnaire consists of 6 questions. * Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score for this section ranges from 0-24.
Outcome measures
| Measure |
Radiation + FOLFOX
n=54 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=7 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Emotional Well-Being)
Baseline
|
18.52 score on FACT-C scale
Standard Deviation 3.75
|
16 score on FACT-C scale
Standard Deviation 4.86
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Emotional Well-Being)
Completion of chemo
|
19.78 score on FACT-C scale
Standard Deviation 3.37
|
14 score on FACT-C scale
Standard Deviation 6.39
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Emotional Well-Being)
10-14 months post radiation therapy
|
19.39 score on FACT-C scale
Standard Deviation 4.08
|
17 score on FACT-C scale
Standard Deviation 6.08
|
SECONDARY outcome
Timeframe: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapyPopulation: One patient in the Radiation + CAPOX was not evaluable for this outcome measure. Participants are not included in the specified time point if they did not complete the questionnaire.
* Functional Well-Being section of the FACT-C questionnaire consists of 7 questions. * Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score for this section ranges from 0-28.
Outcome measures
| Measure |
Radiation + FOLFOX
n=55 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=7 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Functional Well-Being)
Baseline
|
21.42 score on FACT-C scale
Standard Deviation 4.96
|
15.95 score on FACT-C scale
Standard Deviation 7.84
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Functional Well-Being)
Completion of chemo
|
20.91 score on FACT-C scale
Standard Deviation 6.05
|
15.33 score on FACT-C scale
Standard Deviation 6.09
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Functional Well-Being)
10-14 months post radiation therapy
|
20.53 score on FACT-C scale
Standard Deviation 6.36
|
17 score on FACT-C scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapyPopulation: One patient in the Radiation + CAPOX and one patient in the Radiation + FOLFOX were not evaluable for this outcome measure. Participants are not included in the specified time point if they did not complete the questionnaire.
* Colorectal Cancer Subscale section of the FACT-C questionnaire consists of 7 scored questions. * Answers to the questions range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score for this section ranges from 0-28.
Outcome measures
| Measure |
Radiation + FOLFOX
n=54 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=7 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Colorectal Cancer Subscale)
Baseline
|
22.03 score on FACT-C scale
Standard Deviation 3.88
|
17.43 score on FACT-C scale
Standard Deviation 4.47
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Colorectal Cancer Subscale)
Completion of chemo
|
22.03 score on FACT-C scale
Standard Deviation 4.35
|
18 score on FACT-C scale
Standard Deviation 5.93
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (Colorectal Cancer Subscale)
10-14 months post radiation therapy
|
20.82 score on FACT-C scale
Standard Deviation 5.25
|
19.67 score on FACT-C scale
Standard Deviation 3.06
|
SECONDARY outcome
Timeframe: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapyPopulation: One patient in the Radiation + CAPOX and one patient in the Radiation + FOLFOX were not evaluable for this outcome measure. Participants are not included in the specified time point if they did not complete the questionnaire.
* The FACT-G total score is calculated by adding the Physical Well Being subscale score, Social/Family Well Being subscale score, Emotional Well Being subscale score, and Functional Well Being subscale score * Answers to the questions comprising the subscales range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score ranges from 0-108.
Outcome measures
| Measure |
Radiation + FOLFOX
n=54 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=7 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-G Total Score)
Baseline
|
89.26 score on FACT-G scale
Standard Deviation 12.39
|
74.05 score on FACT-G scale
Standard Deviation 22.01
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-G Total Score)
Completion of chemo
|
88.24 score on FACT-G scale
Standard Deviation 13.21
|
70.97 score on FACT-G scale
Standard Deviation 19.5
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-G Total Score)
10-14 months post radiation therapy
|
88.02 score on FACT-G scale
Standard Deviation 16.06
|
77.89 score on FACT-G scale
Standard Deviation 13.81
|
SECONDARY outcome
Timeframe: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapyPopulation: One patient in the Radiation + CAPOX and one patient in the Radiation + FOLFOX were not evaluable for this outcome measure. Participants are not included in the specified time point if they did not complete the questionnaire.
* The FACT-C-Trial Outcome Index (TOI) total score is calculated by adding the Physical Well Being subscale score, Functional Well Being subscale score, and the Colorectal Cancer subscale score * Answers to the questions comprising the subscales range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score ranges from 0-84.
Outcome measures
| Measure |
Radiation + FOLFOX
n=54 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=7 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-C-TOI Total Score)
Baseline
|
68.68 score on FACT-C-TOI scale
Standard Deviation 10.93
|
51.64 score on FACT-C-TOI scale
Standard Deviation 19.3
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-C-TOI Total Score)
Completion of chemo
|
66.01 score on FACT-C-TOI scale
Standard Deviation 12.9
|
50.83 score on FACT-C-TOI scale
Standard Deviation 17.77
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-C-TOI Total Score)
10-14 months post radiation therapy
|
64.91 score on FACT-C-TOI scale
Standard Deviation 15.18
|
57 score on FACT-C-TOI scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline, Completion of chemo (up to 16 weeks), and 10-14 months after radiation therapyPopulation: One patient in the Radiation + CAPOX and two patients in the Radiation + FOLFOX were not evaluable for this outcome measure. Participants are not included in the specified time point if they did not complete the questionnaire.
* The FACT-C total score is calculated by adding the Physical Well Being subscale score, Social/Family Well Being subscale score, Emotional Well Being subscale score, Functional Well Being subscale score, and the Colorectal Cancer subscale score * Answers to the questions comprising the subscales range from 0=not at all to 4=very much. The higher the total score the lower quality of life. * The total score ranges from 0-136.
Outcome measures
| Measure |
Radiation + FOLFOX
n=53 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=7 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-C Total Score)
Baseline
|
111.32 score on FACT-C scale
Standard Deviation 15.02
|
91.48 score on FACT-C scale
Standard Deviation 26.2
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-C Total Score)
Completion of chemo
|
110.34 score on FACT-C scale
Standard Deviation 16.26
|
88.97 score on FACT-C scale
Standard Deviation 24.91
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire (FACT-C Total Score)
10-14 months post radiation therapy
|
108.84 score on FACT-C scale
Standard Deviation 20.44
|
97.56 score on FACT-C scale
Standard Deviation 13.13
|
SECONDARY outcome
Timeframe: At 1 yearOutcome measures
| Measure |
Radiation + FOLFOX
n=53 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=8 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Organ Preservation Rate
|
58.49 percentage of participants
Interval 44.13 to 71.86
|
37.5 percentage of participants
Interval 9.9 to 81.59
|
SECONDARY outcome
Timeframe: At 2 yearsOutcome measures
| Measure |
Radiation + FOLFOX
n=53 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=7 Participants
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Organ Preservation Rate
|
52.83 percentage of participants
Interval 38.64 to 66.7
|
42.86 percentage of participants
Interval 9.9 to 81.59
|
Adverse Events
Radiation + FOLFOX
Serious events: 21 serious events
Other events: 31 other events
Deaths: 1 deaths
Radiation + CAPOX
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiation + FOLFOX
n=55 participants at risk
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=8 participants at risk
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Cardiac disorders
Congestive heart failure
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Gastric ulcer
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Gastritis
|
3.6%
2/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Intestinal malrotation
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
General disorders
Fatigue
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Infections and infestations
Device related infection
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Infections and infestations
Lung infection
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Infections and infestations
Sepsis
|
3.6%
2/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Infections and infestations
Skin infection
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Infections and infestations
Soft tissue infection
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Infections and infestations
Subcutaneous abscess
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Biliary anastomotic leak
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
2/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Hematoma
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Injury, poisoning and procedural complications
Ileostomy complications
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Acidosis
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Psychiatric disorders
Delirium
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Vascular disorders
Hypotension
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Vascular disorders
Superior vena cava syndrome
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Vascular disorders
Thromboembolic event
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
Other adverse events
| Measure |
Radiation + FOLFOX
n=55 participants at risk
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* FOLFOX should begin 2-4 weeks after completion of radiotherapy and will consist of FOLFOX x 8 cycles (16 weeks).
* Oxaliplatin day 1 every 14 days
* Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.
* 5-FU bolus day 1 every 14 days
* 5-FU infusion day 1 every 14 days over 46 hours
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
Radiation + CAPOX
n=8 participants at risk
* Pelvic radiotherapy 5GY x 5 fractions once daily
* Radiation to extra-mesorectal node 7 Gy x 5 fractions once daily
* CAPOX should begin 2-4 weeks after completion of radiotherapy and will consist of CAPOX x 5 cycles (15 weeks).
* Capecitabine 1000 mg/m\^2 by mouth twice per day on days 1-14 of every 21 day cycle
* Oxaliplatin 130 mg/m\^2 intravenous on day 1 of each 21 day cycle
* An optional simultaneous integrated boost of 30 Gy in 5 fractions to the primary tumor is permitted
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Diarrhea
|
10.9%
6/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Gastrointestinal disorders
Proctitis
|
3.6%
2/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
General disorders
Fatigue
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Infections and infestations
Cellulitis
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Investigations
Aspartate aminotransferase increased
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Investigations
Lymphocyte count decreased
|
9.1%
5/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Investigations
Neutrophil count decreased
|
36.4%
20/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Investigations
Platelet count decreased
|
7.3%
4/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Investigations
Weight loss
|
0.00%
0/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Investigations
White blood cell decreased
|
14.5%
8/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
25.0%
2/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.6%
2/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
2/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Nervous system disorders
Dysesthesia
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Nervous system disorders
Paresthesia
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.8%
1/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Psychiatric disorders
Depression
|
0.00%
0/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
12.5%
1/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
|
Vascular disorders
Hypertension
|
3.6%
2/55 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
0.00%
0/8 • Adverse events were collected from start of treatment through 1 year after the start of radiation therapy. All-cause mortality was collected from start of treatment through completion of follow-up (up to 2 years after completion of chemoradiation).
Grade 1-2 adverse events were not collected per protocol unless they were considered a serious adverse event.
|
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