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Recruiting Phase 2 NCT05491512

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

Trial Parameters

Condition HPV
Sponsor Memorial Sloan Kettering Cancer Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 121
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-08-04
Completion 2026-08-04
Interventions
18 F-FMISO PET/CTRadiationCisplatin

Brief Summary

The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with standard-of-care chemotherapy in people with HPV-positive throat cancer. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluorouracil (5- FU), paclitaxel and abraxane- (Albumin-bound Paclitaxel).

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 2. Patient must have excisional biopsy or core biopsy done in order to be on protocol * Subjects must have clinically or radiographically evident measurable gross disease at either the primary tumor site or nodal stations. * Oropharyngeal Carcinoma (AJCC, 7th ed.) without evidence of distant metastasis based on FDG PET/CT. * CT or MRI of the neck with and without contrast Note: A CT scan of neck and/or a PET/CT performed for the purposes of radiation planning may serve as planning tools. * ECOG Performance Status of 0-2 or KPS ≥ 50 * Age ≥ 18 Patients over 70y

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