Phase III Trial Comparing Modified and Standard Radiotherapy to Protect Thyroid Function in Nasopharyngeal Carcinoma Patients

What this Trial Is About

Researchers are conducting a multicenter, open-label, randomized Phase III clinical trial to compare two types of radiotherapy approaches for patients with nasopharyngeal carcinoma. The study focuses on evaluating how well modified delineation radiotherapy protects thyroid function compared to standard delineation radiotherapy. Important outcomes include the incidence of primary hypothyroidism, quality of life, and any adverse events experienced by participants. The trial involves two groups one receiving modified delineation radiotherapy which adjusts the target area to spare the common carotid artery and reduce thyroid radiation exposure, and the other receiving standard delineation radiotherapy with the usual target boundaries. The modified approach changes the medial and anterior boundaries of the lymphatic drainage areas to potentially lessen thyroid damage. This study spans multiple centers and follows patients during their treatment. Participants will undergo regular follow-ups to monitor regional recurrence-free survival over three years, alongside assessments of overall survival, disease-free survival, and hypothyroidism-free survival. Quality of life will be evaluated at one, two, and three years after treatment. The study includes clinical evaluations, thyroid function tests, and safety monitoring to track outcomes and side effects. Total participant involvement may last several years to capture long-term effects and treatment impact.

Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC