Personalized Postoperative Radiation Therapy for Head and Neck Squamous Cell Carcinoma A Phase II Study to Reduce Side Effects by Targeting Treatment Areas

What this Trial Is About

Researchers are evaluating a personalized approach to postoperative radiotherapy for patients with head and neck squamous cell carcinoma HNSCC. This phase II multicenter trial studies whether a risk-adapted, compartmentalized radiotherapy strategy can safely reduce treatment volumes and side effects without increasing tumor recurrence risk. The study focuses on patients with surgically treated cancers of the oral cavity, oropharynx, larynx, or hypopharynx who have a standard indication for postoperative radiotherapy. Participants will receive pathology- and imaging-guided compartmentalized postoperative radiotherapy PORT, with or without systemic treatment, where selected anatomical volumes may be intentionally omitted based on a predefined algorithm. This single-arm study aims to assess the safety of this de-escalated treatment, with dose and volume adapted to risk. The study includes accrual over 24 months and follow-up for each patient for 30 months. During the trial, patients will undergo baseline imaging and assessments of toxicity and quality of life. Researchers will monitor recurrence rates in the omitted compartments for 30 months, along with secondary outcomes such as loco-regional control, progression-free survival, overall survival, acute and late toxicity, and patient-reported quality of life. Safety will be reviewed after 20 patients have completed 6 months of follow-up, with the total study duration about 5.5 years.

Compartmentalized Postoperative Radiotherapy in Head and Neck Cancer