Trial Outcomes & Findings for Individualized Adaptive De-escalated Radiotherapy for HPV-related Oropharynx Cancer (NCT NCT03416153)
NCT ID: NCT03416153
Last Updated: 2026-08-07
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
2026-08-07
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=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=20 Participants
|
23 Participants
n=20 Participants
|
54 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=20 Participants
|
34 Participants
n=20 Participants
|
77 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=20 Participants
|
36 Participants
n=20 Participants
|
83 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
80 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=20 Participants
|
36 participants
n=20 Participants
|
85 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 1 YearPopulation: 1 subject did not proceed with study treatment in the De-escalation treatment
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.
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=35 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, 1 subject did not proceed with study treatment in the De-escalation treatment
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=35 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: at 3 months and 2 yearsPopulation: 1 subject did not proceed with study treatment in the De-escalation treatment
Kaplan-Meier estimate of the percentage of participants who experienced Locoregional relapse versus distant relapse
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=35 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.
|
|---|---|---|
|
Patterns of Failure
3 month Locoregional relapse
|
0 Estimate of percentage of participants
Interval 0.0 to 0.0
|
0 Estimate of percentage of participants
Interval 0.0 to 0.0
|
|
Patterns of Failure
3 month distant relapse
|
0 Estimate of percentage of participants
Interval 0.0 to 0.0
|
0 Estimate of percentage of participants
Interval 0.0 to 0.0
|
|
Patterns of Failure
2 year Locoregional relapse
|
6.8 Estimate of percentage of participants
Interval 0.0 to 13.9
|
9.1 Estimate of percentage of participants
Interval 0.0 to 18.5
|
|
Patterns of Failure
2 year distant relapse
|
4.1 Estimate of percentage of participants
Interval 0.0 to 9.7
|
6.4 Estimate of percentage of participants
Interval 0.0 to 14.6
|
SECONDARY outcome
Timeframe: at 3 months, and 2 YearsPopulation: 1 subject did not proceed with study treatment in the De-escalation treatment
Kaplan-Meier estimate of the percentage of participants who are still alive at 3 months and 2 years.
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=35 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.
|
|---|---|---|
|
Overall Survival
3 months
|
98.0 Estimate of percentage of participants
Interval 94.1 to 100.0
|
100 Estimate of percentage of participants
Interval 100.0 to 100.0
|
|
Overall Survival
2 years
|
95.8 Estimate of percentage of participants
Interval 90.2 to 100.0
|
97.0 Estimate of percentage of participants
Interval 91.3 to 100.0
|
SECONDARY outcome
Timeframe: at 3 months and 2 yearsPopulation: 1 subject did not proceed with study treatment in the De-escalation treatment
Kaplan-Meier estimate of the percentage of participants who are still in progression free survival at 3 months and 2 years
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=35 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.
|
|---|---|---|
|
Progression- Free Survival
3 months
|
98.0 Estimate of percentage of participants
Interval 94.1 to 100.0
|
100 Estimate of percentage of participants
Interval 100.0 to 100.0
|
|
Progression- Free Survival
2 years
|
87.5 Estimate of percentage of participants
Interval 78.6 to 97.4
|
84.7 Estimate of percentage of participants
Interval 73.2 to 98.0
|
SECONDARY outcome
Timeframe: 1, 3 and 12 monthsPopulation: number analyzed updates as subjects progressed through study
Toxicity outcomes will be estimated as proportions of patients with available toxicity data at 1, 3 and 12 months. XQ, Xerostomia Questionnaire, is scored on a scale of 0-100 with higher score indicating worse xerostomia. HN, FACT-HN, is scored on a scale of 0-190 with higher score indicating a better quality of life.
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=35 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.
|
|---|---|---|
|
Incidence of Toxicity
Xerostomia Questionnaire- 1 month
|
45 Estimated mean score
Interval 38.8 to 51.1
|
33.3 Estimated mean score
Interval 26.4 to 40.3
|
|
Incidence of Toxicity
Xerostomia Questionnaire- 12 months
|
26.6 Estimated mean score
Interval 19.8 to 33.5
|
25.3 Estimated mean score
Interval 17.7 to 32.9
|
|
Incidence of Toxicity
FACT-HN- 1 month
|
26.1 Estimated mean score
Interval 24.6 to 27.7
|
23.1 Estimated mean score
Interval 21.4 to 24.8
|
|
Incidence of Toxicity
Xerostomia Questionnaire- 3 months
|
35.7 Estimated mean score
Interval 21.2 to 50.1
|
36.7 Estimated mean score
Interval 23.3 to 50.0
|
|
Incidence of Toxicity
FACT-HN- 3 months
|
23.5 Estimated mean score
Interval 19.9 to 27.1
|
20.9 Estimated mean score
Interval 17.6 to 24.2
|
|
Incidence of Toxicity
FACT-HN- 12 months
|
16.9 Estimated mean score
Interval 15.2 to 18.6
|
15.3 Estimated mean score
Interval 13.4 to 17.2
|
SECONDARY outcome
Timeframe: from Baseline up to 7 weeksPopulation: number analyzed updates as subjects progressed through study
Median values of ctDNA molecules present throughout the study. The week 6/7 measurement is taken as the first measurement that was available during weeks 6 and 7 to minimize missing data and to account for minor timing deviations in sample collection during weeks 6 and 7
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=35 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.
|
|---|---|---|
|
Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants
Week 3
|
119 ctDNA targets/mL
Interval 8.0 to 648.0
|
58 ctDNA targets/mL
Interval 0.0 to 414.0
|
|
Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants
Week 1
|
51 ctDNA targets/mL
Interval 7.0 to 1231.0
|
66 ctDNA targets/mL
Interval 29.0 to 493.0
|
|
Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants
Week 2
|
174 ctDNA targets/mL
Interval 67.0 to 706.0
|
277 ctDNA targets/mL
Interval 74.0 to 681.0
|
|
Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants
Baseline
|
687 ctDNA targets/mL
Interval 80.0 to 2268.0
|
273 ctDNA targets/mL
Interval 81.0 to 963.0
|
|
Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants
Week 4
|
8 ctDNA targets/mL
Interval 0.0 to 133.0
|
0 ctDNA targets/mL
Interval 0.0 to 4.0
|
|
Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants
Week 5
|
0 ctDNA targets/mL
Interval 0.0 to 10.0
|
0 ctDNA targets/mL
Interval 0.0 to 0.0
|
|
Detectable Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Participants
Week 6/7
|
0 ctDNA targets/mL
Interval 0.0 to 0.0
|
0 ctDNA targets/mL
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED 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
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 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.0%
1/49 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Cardiac disorders
Cardiac arrest
|
4.1%
2/49 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/49 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/49 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/49 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Infections and infestations
Lung infection
|
2.0%
1/49 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Musculoskeletal and connective tissue disorders
Oral hemorrhage
|
2.0%
1/49 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Musculoskeletal and connective tissue disorders
Oral pain
|
2.0%
1/49 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
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.
|
|---|---|---|
|
General disorders
Abdominal pain
|
8.2%
4/49 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Investigations
Alanine aminotransferase increased
|
10.2%
5/49 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Investigations
Anemia
|
8.2%
4/49 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Psychiatric disorders
Anorexia
|
14.3%
7/49 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Psychiatric disorders
Anxiety
|
16.3%
8/49 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
11.1%
4/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Gastrointestinal disorders
Constipation
|
63.3%
31/49 • Number of events 38 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
52.8%
19/36 • Number of events 21 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Dehydration
|
42.9%
21/49 • Number of events 27 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
16.7%
6/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis radiation
|
81.6%
40/49 • Number of events 77 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
75.0%
27/36 • Number of events 35 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Gastrointestinal disorders
Diarrhea
|
10.2%
5/49 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
19.4%
7/36 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Dizziness
|
10.2%
5/49 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
11.1%
4/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Dry mouth
|
95.9%
47/49 • Number of events 74 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
91.7%
33/36 • Number of events 47 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Dysgeusia
|
100.0%
49/49 • Number of events 84 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
97.2%
35/36 • Number of events 54 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Dysphagia
|
77.6%
38/49 • Number of events 68 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
69.4%
25/36 • Number of events 36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Ear and labyrinth disorders
Ear pain
|
22.4%
11/49 • Number of events 12 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
22.2%
8/36 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Gastrointestinal disorders
Esophageal pain
|
55.1%
27/49 • Number of events 35 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
13.9%
5/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Gastrointestinal disorders
Esophagitis
|
8.2%
4/49 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Fatigue
|
100.0%
49/49 • Number of events 58 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
75.0%
27/36 • Number of events 33 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.2%
4/49 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Headache
|
16.3%
8/49 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
8.3%
3/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Psychiatric disorders
Insomnia
|
12.2%
6/49 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Vascular disorders
Lymphedema
|
16.3%
8/49 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Investigations
Lymphocyte count decreased
|
12.2%
6/49 • Number of events 17 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
8.3%
3/36 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Gastrointestinal disorders
Mucositis oral
|
93.9%
46/49 • Number of events 87 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
88.9%
32/36 • Number of events 41 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Gastrointestinal disorders
Nausea
|
65.3%
32/49 • Number of events 49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
61.1%
22/36 • Number of events 25 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.2%
4/49 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Musculoskeletal and connective tissue disorders
Oral pain
|
95.9%
47/49 • Number of events 80 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
72.2%
26/36 • Number of events 34 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Pain
|
65.3%
32/49 • Number of events 59 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
72.2%
26/36 • Number of events 35 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Skin and subcutaneous tissue disorders
Radiation recall reaction (dermatologic)
|
8.2%
4/49 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Sore throat
|
40.8%
20/49 • Number of events 23 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
33.3%
12/36 • Number of events 12 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Infections and infestations
Thrush
|
14.3%
7/49 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
18.4%
9/49 • Number of events 10 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
11.1%
4/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Gastrointestinal disorders
Vomiting
|
8.2%
4/49 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
11.1%
4/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Investigations
Weight loss
|
73.5%
36/49 • Number of events 45 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
55.6%
20/36 • Number of events 21 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Vascular disorders
Hypotension
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
16.7%
6/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
3/49 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Cough
|
6.1%
3/49 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Edema limbs
|
6.1%
3/49 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Generalized muscle weakness
|
6.1%
3/49 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Hoarseness
|
6.1%
3/49 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Investigations
Hypomagnesemia
|
6.1%
3/49 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
0.00%
0/36 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Cardiac disorders
Hypotension
|
6.1%
3/49 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
16.7%
6/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Arthralgia
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
11.1%
4/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Fever
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Hemorrhoids
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Hiccups
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Investigations
Hyperglycemia
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Renal and urinary disorders
Hyperhidrosis
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Renal and urinary disorders
Hyponatremia
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
Investigations
Infusion related reaction
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
11.1%
4/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
|
General disorders
Paresthesia
|
0.00%
0/49 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
8.3%
3/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through up to 2 years of follow up, for a median of 36.2 months for Cohort A and 39.6 months for Cohort B.
|
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