Study of Reduced Volume and Dose Radiotherapy for p16-Positive Oropharyngeal Squamous Cell Carcinoma

What this Trial Is About

This research evaluates a reduced volume and dose radiotherapy approach for patients with p16-positive squamous cell carcinoma of the oropharynx. The study focuses on treating the primary tumor and involved lymph nodes with lower radiation doses while omitting certain lymph node regions from treatment. It is designed as a multi-center, single-arm prospective cohort study to assess the effects of this de-intensified radiotherapy strategy. Participants receive radiotherapy delivering 60 Gy to the primary tumor and involved nodes and 54 Gy to subclinical regions at risk, over 30 fractions. Chemotherapy is given alongside as per standard care, with options including high-dose or low-dose cisplatin or cetuximab based on the oncologists decision. The radiation targets reduced elective nodal volumes, specifically omitting level IB lymph nodes. During the study, participants undergo monitoring for xerostomia-related quality of life at 12 months and adverse event toxicity criteria from baseline through 5 years. Assessments include clinical evaluations and follow-up visits to track treatment effects and safety. The total duration includes long-term follow-up to understand the impact of the de-intensified treatment approach on patient outcomes.

p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)