Trial Outcomes & Findings for Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer (NCT NCT03416153)
NCT ID: NCT03416153
Last Updated: 2025-05-22
Results Overview
RECIST (Response Evaluation Criteria In Solid Tumors) will be used to evaluate response and recurrence. All patients will be analyzed together as the goal of the study is to estimate risk of LRR in this patient population treated with this particular strategy in which some patients continue to receive standard therapy while others are de-escalated. Results will also be estimated and reported separately for patients receiving standard or de-escalated therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
1 Year
Results posted on
2025-05-22
Participant Flow
6 subjects were removed from the trial before being assigned a cohort.
Participant milestones
| Measure |
Standard Treatment
Patients received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy)
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
De-escalation Treatment
Patients initially received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions.
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
36
|
|
Overall Study
COMPLETED
|
47
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Standard Treatment
Patients received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy)
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
De-escalation Treatment
Patients initially received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions.
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer
Baseline characteristics by cohort
| Measure |
Standard Treatment
n=49 Participants
Patients received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy)
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
De-escalation Treatment
n=36 Participants
Patients initially received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions.
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=99 Participants
|
36 participants
n=107 Participants
|
85 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 YearRECIST (Response Evaluation Criteria In Solid Tumors) will be used to evaluate response and recurrence. All patients will be analyzed together as the goal of the study is to estimate risk of LRR in this patient population treated with this particular strategy in which some patients continue to receive standard therapy while others are de-escalated. Results will also be estimated and reported separately for patients receiving standard or de-escalated therapy.
Outcome measures
| Measure |
Standard Treatment
n=49 Participants
Patients received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy)
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
De-escalation Treatment
n=36 Participants
Patients initially received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions.
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
|---|---|---|
|
The Percentage of Patients With Local Regional Recurrence (LRR) of Disease
|
2 percentage of participants
Interval 0.0 to 6.0
|
3 percentage of participants
Interval 0.0 to 8.0
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: 2 patients were not evaluable
The change in metabolic tumor volume (MTV)50% at the mid-treatment timepoint will be calculated as percent change from baseline and used as a continuous variable in a Cox model for an outcome of time to LRR. Will also evaluate more non-parametrically, the relation between hazard of LRR and mid-treatment MTV50% using a kernel estimator in a Cox model.
Outcome measures
| Measure |
Standard Treatment
n=47 Participants
Patients received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy)
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
De-escalation Treatment
n=36 Participants
Patients initially received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions.
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
|---|---|---|
|
Change in Metabolic Tumor Volume 50% (MTV 50%)
|
-11.3 percent change from baseline
Standard Deviation 66.7
|
-71.1 percent change from baseline
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: 2 YearsQuality of life (QOL) outcomes and swallowing study results will be summarized descriptively by timepoint. If there is substantial missingness in the QOL outcomes the study will assess for informative missingness by comparing earlier QOL scores and change in earlier QOL scores between patients missing QOL at later time points (e.g. 1 or 2 years).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 YearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3, 6, 12 and 24 MonthsToxicity outcomes will be estimated as proportions of patients with available toxicity data at 3, 6 12 and 24 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksThe proportion of patients in whom ctDNA is detectable will be summarized as a binomial proportion at each timepoint. Additionally, the relation between ctDNA presence or other characteristics and patient outcomes including time to local or distant progression will be assessed by including ctDNA as a covariate in Cox models for local or distant control.
Outcome measures
Outcome data not reported
Adverse Events
Standard Treatment
Serious events: 5 serious events
Other events: 49 other events
Deaths: 2 deaths
De-escalation Treatment
Serious events: 3 serious events
Other events: 36 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standard Treatment
n=49 participants at risk
Patients received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy)
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
De-escalation Treatment
n=36 participants at risk
Patients initially received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions.
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
2.0%
1/49 • Number of events 1 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.0%
1/49 • Number of events 1 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Cardiac disorders
Cardiac arrest
|
4.1%
2/49 • Number of events 2 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/49 • Number of events 1 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/49 • Number of events 1 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
2.8%
1/36 • Number of events 1 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/49 • Number of events 1 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/49 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
2.8%
1/36 • Number of events 1 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Infections and infestations
Lung infection
|
2.0%
1/49 • Number of events 1 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Musculoskeletal and connective tissue disorders
Oral hemorrhage
|
2.0%
1/49 • Number of events 1 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Musculoskeletal and connective tissue disorders
Oral pain
|
2.0%
1/49 • Number of events 1 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/49 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
2.8%
1/36 • Number of events 1 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
Other adverse events
| Measure |
Standard Treatment
n=49 participants at risk
Patients received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy)
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
De-escalation Treatment
n=36 participants at risk
Patients initially received a single prescription of 70 Gy in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). If certain parameters are met radiation therapy will be reduced to 54Gy to high risk Planned Target Volume (PTV) and 43.2Gy to low risk PTV all in 27 fractions.
Carboplatin: AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
Radiation Therapy: Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
Paclitaxel: 30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
63.3%
31/49 • Number of events 38 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
50.0%
18/36 • Number of events 20 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
General disorders
Dehydration
|
42.9%
21/49 • Number of events 27 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
16.7%
6/36 • Number of events 6 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
General disorders
Abdominal pain
|
8.2%
4/49 • Number of events 4 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Investigations
Alanine aminotransferase increased
|
10.2%
5/49 • Number of events 5 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Investigations
Anemia
|
8.2%
4/49 • Number of events 5 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Psychiatric disorders
Anorexia
|
14.3%
7/49 • Number of events 7 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Psychiatric disorders
Anxiety
|
16.3%
8/49 • Number of events 8 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Skin and subcutaneous tissue disorders
Dermatitis radiation
|
79.6%
39/49 • Number of events 75 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
69.4%
25/36 • Number of events 32 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Gastrointestinal disorders
Diarrhea
|
10.2%
5/49 • Number of events 7 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
19.4%
7/36 • Number of events 7 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
General disorders
Dizziness
|
10.2%
5/49 • Number of events 5 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
11.1%
4/36 • Number of events 5 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
General disorders
Dry mouth
|
93.9%
46/49 • Number of events 73 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
86.1%
31/36 • Number of events 45 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
General disorders
Dysgeusia
|
100.0%
49/49 • Number of events 81 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
91.7%
33/36 • Number of events 51 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
General disorders
Dysphagia
|
75.5%
37/49 • Number of events 66 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
66.7%
24/36 • Number of events 34 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Ear and labyrinth disorders
Ear pain
|
22.4%
11/49 • Number of events 12 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
22.2%
8/36 • Number of events 9 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Gastrointestinal disorders
Esophageal pain
|
55.1%
27/49 • Number of events 35 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
13.9%
5/36 • Number of events 5 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Gastrointestinal disorders
Esophagitis
|
8.2%
4/49 • Number of events 4 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
General disorders
Fatigue
|
98.0%
48/49 • Number of events 57 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
69.4%
25/36 • Number of events 31 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.2%
4/49 • Number of events 4 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
General disorders
Headache
|
16.3%
8/49 • Number of events 9 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Psychiatric disorders
Insomnia
|
12.2%
6/49 • Number of events 6 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Vascular disorders
Lymphedema
|
16.3%
8/49 • Number of events 8 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Investigations
Lymphocyte count decreased
|
12.2%
6/49 • Number of events 17 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Gastrointestinal disorders
Mucositis oral
|
91.8%
45/49 • Number of events 85 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
83.3%
30/36 • Number of events 39 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Gastrointestinal disorders
Nausea
|
65.3%
32/49 • Number of events 49 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
55.6%
20/36 • Number of events 23 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.2%
4/49 • Number of events 4 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Musculoskeletal and connective tissue disorders
Oral pain
|
95.9%
47/49 • Number of events 80 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
69.4%
25/36 • Number of events 33 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
General disorders
Pain
|
65.3%
32/49 • Number of events 59 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
72.2%
26/36 • Number of events 35 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Skin and subcutaneous tissue disorders
Radiation recall reaction (dermatologic)
|
8.2%
4/49 • Number of events 6 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
General disorders
Sore throat
|
38.8%
19/49 • Number of events 22 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
27.8%
10/36 • Number of events 10 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Infections and infestations
Thrush
|
14.3%
7/49 • Number of events 7 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
0.00%
0/36 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
18.4%
9/49 • Number of events 10 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
11.1%
4/36 • Number of events 4 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Gastrointestinal disorders
Vomiting
|
8.2%
4/49 • Number of events 4 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
11.1%
4/36 • Number of events 5 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Investigations
Weight loss
|
73.5%
36/49 • Number of events 45 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
52.8%
19/36 • Number of events 20 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
|
Vascular disorders
Hypotension
|
0.00%
0/49 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
16.7%
6/36 • Number of events 6 • Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected. Results currently reported were collected over a 5 year period.
Adverse Events and All-Cause Mortality have been reported through the time of PCC. Data is still being collected.
|
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place