Reduced Dose Radiation Treatment Guided by HPV DNA Testing for Head and Neck Squamous Cell Carcinoma A Phase 2 Study Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the safety and effectiveness of lower doses of radiation therapy for treating head and neck squamous cell carcinomas, specifically HPV-positive oropharyngeal squamous cell cancers. This study aims to see if reducing the radiation dose can prevent cancer recurrence while causing fewer side effects compared to standard radiation treatments. It is a phase 2 trial sponsored by the University of Virginia. Participants will receive a reduced radiation dose regimen with variations depending on whether they receive concurrent chemotherapy and their response to treatment as measured by a specialized blood test called NavDx. The radiation dose and volume are decreased compared to standard care, and those who respond slowly to treatment may get an additional radiation boost. Treatment includes 24 Gy in 12 fractions to the main tumor and intermediate lymph nodes, followed by either 30 or 36 Gy to the entire volume, with possible extra doses for non-rapid responders. Throughout the study, participants will undergo routine NavDx testing to monitor treatment response and detect cancer recurrence. They will also complete surveys about their overall health and quality of life. The primary outcome is disease control assessed up to two years after radiation. Safety and quality of life will be evaluated at intervals up to one and two years after treatment, respectively. The study involves non-randomized assignment and does not use masking.

HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma