Randomized Trial Comparing Radiation Therapy Approaches to Preserve Swallowing After Oral Cavity Squamous Cell Carcinoma Surgery

What this Trial Is About

This research aims to compare quality of life in patients who have had surgery to remove squamous cell carcinoma of the oral cavity and have at least one pN0 hemi-neck. The study evaluates two different radiation therapy approaches after surgery a primary radiation therapy covering all dissected areas and a secondary targeted radiation therapy focusing only on the tumor location. This randomized trial seeks to provide strong evidence to help guide treatment choices for these patients. Participants will be randomly assigned in a 23 ratio to one of two groups. One group receives standard radiation therapy to the tumor and all dissected areas, while the other group receives targeted radiation therapy that avoids irradiating the pN0 neck. Both treatments may include chemotherapy based on historical treatment volumes and physician recommendations. The study will follow patients for a total of five years to monitor outcomes. Throughout the study, participants will undergo evaluations of their swallowing quality of life and health status for up to 12 months, as well as assessments of survival, disease recurrence, toxicity, and swallowing function for up to five years. Researchers will carefully track regional failures in the pN0 hemi-neck and the need for additional salvage treatments. Participants will also complete quality of life questionnaires, and safety will be monitored over the long term.

Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial