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Recruiting Phase 2 NCT06984861

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

Trial Parameters

Condition Oropharyngeal Carcinoma
Sponsor Memorial Sloan Kettering Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 74
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-05-13
Completion 2028-05
Interventions
18F-FMISO PET/CT ScanChemoradiationQuestionnaires

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).

Eligibility Criteria

Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) from biopsy, surgical resection or excisional biopsy regardless of margin status. 1. Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy of a lymph node (or core biopsy) or consent from the PI or co-PI. Patient must have excisional biopsy or core biopsy done in order to be on protocol. Note: Evidence of HPV associated oropharyngeal cancer from either the primary tumor site or from a lymph node. A patient is HPV positive when he or she tests positive having tested positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization. * Subjects must have clinically or radiographically evident measurable gross disease at either the primary tumor site or nodal stations. * T3-4/N0-2c or any N3 regardl

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