NCT06752239

Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC

Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in Nasopharyngeal Carcinoma (PROTECT-NPC): A Multicenter, Non-Inferiority, Open-Label, Randomized Controlled Phase III Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 474 (estimated)
• Sponsor: Jiangxi Provincial Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, non-inferiority, open-label, randomized controlled Phase III clinical trial. It aims to compare the efficacy of modified delineation radiotherapy (experimental group) versus standard delineation radiotherapy (control group) in the prophylactic irradiation of neck lymphatic drainage areas III/IVa in nasopharyngeal carcinoma. The study evaluates the incidence of primary hypothyroidism, quality of life, and adverse events between the two groups.

Conditions

• Nasopharyngeal Carcinoma
• Quality of Life
• Thyroid Diseases
• Radiotherapy Side Effect
• Radiotherapy

Interventions

Type	Name	Description
RADIATION	Modified delineation	Modified delineation (MD) of cervical lymphatic drainage areas, sparing the common carotid artery within the clinical target volume (CTV)
RADIATION	Standard delineation	Standard delineation

Timeline

• Start date: 2025-01-01
• Primary completion: 2030-12-31
• Completion: 2031-12-31
• First posted: 2024-12-30
• Last updated: 2025-04-10

Locations

1 site across 1 country: China