Phase III Randomized Double-blinded Trial Comparing Personalized De-escalated Radiation Versus Standard Radiation in HPV Positive Oropharyngeal Cancer

What this Trial Is About

Researchers are evaluating a personalized approach to chemoradiation therapy compared to standard chemoradiation therapy in people with HPV-positive throat cancer. This study aims to find out if using a lower dose of radiation with standard chemotherapy is as effective as the standard radiation dose combined with chemotherapy. The study also looks at whether the lower radiation dose causes fewer side effects and how each treatment affects patients quality of life, measured through questionnaires. Participants will be randomly assigned to one of two treatment groups. One group receives personalized chemoradiation therapy where radiation dose is adjusted based on tumor hypoxia detected by a special FMISO-PET scan hypoxia-negative patients receive 30 Gy of radiation, while hypoxia-positive patients receive 70 Gy. The other group receives the standard chemoradiation therapy of 70 Gy radiation regardless of hypoxia status. Both groups receive concurrent chemotherapy as per guidelines. After treatment, a PETCT scan is done about four months later to check for persistent disease, and further standard care is provided as needed. During the study, participants will undergo the FMISO-PET scan, routine chemotherapy and radiation treatments, and quality of life assessments using specific questionnaires. Researchers will monitor overall survival over two years as the primary outcome. Safety and treatment effects will be evaluated through follow-up scans and clinical assessments. Participation involves regular visits for scans, treatments, and questionnaires, with the study lasting at least two years to assess outcomes.

A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer