NCT05780372

Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: a Multi-center, Non-inferiority, Open-label, Randomized Controlled Phase III Clinical Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 474 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.

Conditions

• Nasopharyngeal Carcinoma
• Radiotherapy; Complications

Interventions

Type	Name	Description
RADIATION	Intensity Modulated Radiation Therapy	All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
DRUG	Chemotherapy	Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.

Timeline

• Start date: 2023-08-08
• Primary completion: 2025-05-01
• Completion: 2028-05-01
• First posted: 2023-03-22
• Last updated: 2025-01-28

Locations

7 sites across 1 country: China