Recruiting
PHASE2
INTERVENTIONAL
NCT06984861
A Study of Reduced Radiation Therapy With Chemotherapy in People With HPV-Positive Throat Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The researchers are doing this study is to find out if lower doses (given in fewer treatments over a shorter period of time) of radiation therapy in combination with standard-of-care chemotherapy is an effective treatment for people with Human Papilloma Virus (HPV)-positive throat cancer and works as well as the standard doses of radiation therapy in combination with standard-of-care chemotherapy. The chemotherapy drugs used in combination with radiation therapy in this study include cisplatin, carboplatin, and 5-fluorouracil (5-FU).
Interventions
Name:
18F-FMISO PET/CT Scan
Type:
DIAGNOSTIC_TEST
Description:
The 18F-FMISO PET/CT Scan Protocol consists first of an IV bolus injection of approximately 5-10 mCi of the radiotracer. Subjects will undergo 18F-FMISO scan (only 1 injection) occurs at 8-10 treatment days\* into chemoradiation. Each patient will have a baseline staging FDG PET scan which is used to localize the tumor at the primary site and all suspicious cervical neck nodes (\> 1 cm in short axis diameter with focal abnormal increased FDG avidity). These lesions are then assessed on the respective 18F-FMISO PET/CT.
Name:
Chemoradiation
Type:
COMBINATION_PRODUCT
Description:
Patients will start with induction chemotherapy of carboplatin, paclitaxel and cetuximab for 6 weeks and when downstaged to T1-2 and \< N3, the patient is eligible to receive concurrent chemoradiation per protocol.A total radiation therapy of 30Gy will be delivered to the oropharynx and neck at 2Gy per fraction per day over 15 days for patients who exhibited no evidence of hypoxia on the intra-treatment 18F-FMISO PET/CT. Concurrent chemotherapy (2 cycles) will be given. After completion of chemotherapy and radiation therapy, a 4 month (+/- 4 weeks)
Name:
Questionnaires
Type:
OTHER
Description:
EQ-5D-5L, MDADI-HN, COST-FACIT
Primary Outcomes
Measure:
Locoregional control
TimeFrame:
2 years
Description:
Researchers will test the null hypothesis H0: P=78% vs the alternative hypothesis H1:P=91%, where P represents the 2-year locoregional control (LRC). We will use the Kaplan-Meier method to estimate the LRC rate at 2 years and construct a 0.975 1-sided confidence interval in order to achieve a test size alpha = 0.05 (this is based on a finite-sample correction using 100,000 simulations).
Trial Information
NCT ID
NCT06984861
Status
Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Memorial Sloan Kettering Cancer Center
Last Updated
December 15, 2025