A Study of Reduced Radiation Therapy With Chemotherapy in People With HPV-Positive Throat Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

May 13, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

May 31, 2028

Conditions
Oropharyngeal Carcinoma
Interventions
DIAGNOSTIC_TEST

18F-FMISO PET/CT Scan

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.

COMBINATION_PRODUCT

Chemoradiation

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)

OTHER

Questionnaires

EQ-5D-5L, MDADI-HN, COST-FACIT

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities), Commack

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER