Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCSD UCSF
Dates
study started
completion around

Description

Summary

This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human papillomavirus (HPV)-positive oropharyngeal cancer that is early in its growth and may not have spread to other parts of the body (early-stage), and is not associated with smoking. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see if a reduced dose of radiation therapy and nivolumab works as well as standard dose radiation therapy and cisplatin in treating patients with oropharyngeal cancer.

Official Title

A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

Details

Keywords

Basaloid Squamous Cell Carcinoma, Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Oropharyngeal Squamous Cell Carcinoma, Papillary Squamous Cell Carcinoma, Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Squamous Cell Carcinoma, Carcinoma, Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Deoxyglucose, Cisplatin, Nivolumab, Fluorodeoxyglucose F18, Biopsy, Biospecimen Collection, Computed Tomography, Fludeoxyglucose F-18, Image Guided Radiation Therapy, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging, Positron Emission Tomography, Quality-of-Life Assessment, IMRT, IGRT, cisplatin, IMRT, IGRT, nivolumab

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT03952585
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
About 384 people participating
Last Updated