Trial Outcomes & Findings for Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers (NCT NCT03656133)
NCT ID: NCT03656133
Last Updated: 2025-11-18
Results Overview
Fractionation of radiation will be individualized based on patient Proliferation Saturation Index (PSI). Objective is to increase the rate of response of ≥ 32% at 4 weeks to 63% of patients, above the expected 49%. Result is reported as percentage of participants who met the criteria for ≥ 32% reduction in tumor volume by week 4.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
At 4 weeks of treatment
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
Radiotherapy Fractionation
Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy for HPV + Oropharyngeal Cancers
Baseline characteristics by cohort
| Measure |
Radiotherapy Fractionation
n=55 Participants
Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=202 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=202 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=202 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=202 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=202 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=202 Participants
|
PRIMARY outcome
Timeframe: At 4 weeks of treatmentFractionation of radiation will be individualized based on patient Proliferation Saturation Index (PSI). Objective is to increase the rate of response of ≥ 32% at 4 weeks to 63% of patients, above the expected 49%. Result is reported as percentage of participants who met the criteria for ≥ 32% reduction in tumor volume by week 4.
Outcome measures
| Measure |
Radiotherapy Fractionation
n=55 Participants
Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
|
|---|---|
|
Percentage of Response at Week 4 of Treatment
|
61.2 percentage of participants
|
SECONDARY outcome
Timeframe: 2-3 months post treatmentPopulation: Evaluable participants at 2-3 months post treatment
Rate of complete response by Computed Tomography (CT) at 2 months or Positron Emission Topography (PET)/CT at 3 months following completion of therapy
Outcome measures
| Measure |
Radiotherapy Fractionation
n=53 Participants
Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
|
|---|---|
|
Rate of Complete Response at 2-3 Months
Complete anatomic and/or metabolic response
|
98.1 percentage of participants
|
|
Rate of Complete Response at 2-3 Months
Partial anatomic and/or metabolic response
|
2.1 percentage of participants
|
Adverse Events
Radiotherapy Fractionation
Serious events: 1 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Radiotherapy Fractionation
n=55 participants at risk
Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.
|
Other adverse events
| Measure |
Radiotherapy Fractionation
n=55 participants at risk
Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
|
|---|---|
|
Gastrointestinal disorders
Mucositis oral
|
9.1%
5/55 • Number of events 6 • Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.
|
|
Gastrointestinal disorders
Dry mouth
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
5.5%
3/55 • Number of events 4 • Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
3.6%
2/55 • Number of events 3 • Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.8%
1/55 • Number of events 1 • Adverse events were collected from date participant signed informed consent to 7 days for non serious or 30 days for serious adverse events after last day of study participation, an average of 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place