Trial Outcomes & Findings for OPSCC N0 Nodal Control With Reduced IMRT (NCT NCT01891695)
NCT ID: NCT01891695
Last Updated: 2022-10-12
Results Overview
Effectiveness of 39.6 Gy (Gray) radiation on tumor control in the clinically uninvolved (N0) cervical lymphatics of patients with p16+ oropharyngeal squamous cell carcinoma (OPSCCA)
TERMINATED
NA
1 participants
Up to 3 years post treatment
2022-10-12
Participant Flow
Participant milestones
| Measure |
Reduced Intensity Radiation
39.6 Gy radiation to clinically uninvolved cervical lymphatics
39.6 Gy radiation
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OPSCC N0 Nodal Control With Reduced IMRT
Baseline characteristics by cohort
| Measure |
Reduced Intensity Radiation
n=1 Participants
39.6 Gy radiation to clinically uninvolved cervical lymphatics
39.6 Gy radiation
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years post treatmentPopulation: Study was stopped prematurely after 1 subject was enrolled. No analysis was performed.
Effectiveness of 39.6 Gy (Gray) radiation on tumor control in the clinically uninvolved (N0) cervical lymphatics of patients with p16+ oropharyngeal squamous cell carcinoma (OPSCCA)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years post treatmentPopulation: Study was terminated after one subject enrolled. No analysis performed.
Evaluated safety and tolerability of treatment of p16+ OPSCCA by overall incidence of adverse events, incidence of acute and late toxicities and subject-rated quality of life assessments.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years post treatmentPopulation: No analysis performed. Study was terminated after one subject was enrolled.
Patient status reviewed and confirmed through Neck CT and PET scans at follow up time points throughout trial
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 years post treatmentPopulation: Study was halted early. Only one subject was enrolled. No analysis performed.
Comparison of DVH of treatment plans between patients receiving 39.6 Gy versus the standard dose of 50 Gy to the clinically uninvolved neck
Outcome measures
Outcome data not reported
Adverse Events
Reduced Intensity Radiation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reduced Intensity Radiation
n=1 participants at risk
39.6 Gy radiation to clinically uninvolved cervical lymphatics
39.6 Gy radiation
|
|---|---|
|
Psychiatric disorders
depression
|
100.0%
1/1 • Number of events 1
|
|
Infections and infestations
Myelitis
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Dyspahgiz
|
100.0%
1/1 • Number of events 1
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
100.0%
1/1 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
100.0%
1/1 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
1/1 • Number of events 1
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
100.0%
1/1 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
100.0%
1/1 • Number of events 1
|
|
Investigations
Creatinine increased
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
100.0%
1/1 • Number of events 1
|
|
Nervous system disorders
Lethargy
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
1/1 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
100.0%
1/1 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
100.0%
1/1 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 1
|
|
Investigations
WBC decreased
|
100.0%
1/1 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Small intestine obstruction
|
100.0%
1/1 • Number of events 1
|
|
Investigations
Weight loss
|
100.0%
1/1 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place