Reducing Radiation After Surgery in Head and Neck Squamous Cell Carcinoma Comparing Standard and Reduced Elective Nodal Radiotherapy to Lower Side Effects Phase IIIII Randomized Study

What this Trial Is About

Researchers are evaluating a new approach to postoperative radiotherapy in patients with squamous cell carcinoma of the head and neck. This phase IIIII multicenter trial aims to reduce long-term side effects of radiation by eliminating radiotherapy to the elective neck while maintaining strict surgical and radiological standards. The goal is to lower late toxicity without compromising locoregional cancer control. Participants will be randomly assigned to one of two groups the control group will receive standard postoperative radiotherapy including elective nodal irradiation, while the investigational group will have radiotherapy targeted only to the primary tumor and affected lymph nodes without elective nodal irradiation. The study uses a two-stage design, starting with a phase II to measure 1-year feeding tube dependence followed by a phase III to assess locoregional control if initial results are favorable. During the study, participants will undergo radiotherapy according to their assigned group, followed by monitoring of outcomes such as feeding tube dependence, disease-free survival, overall survival, and toxicity levels. Researchers will use imaging and clinical assessments to track cancer recurrence and side effects. The study expects up to 26 months of follow-up to evaluate long-term effects and treatment success.

De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck