NCT07201337

Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.

A Randomized, Open-Label, Non-Inferiority Phase III Multicenter Clinical Trial Comparing Reduced-Dose to Standard-Dose Prophylactic Irradiation for Low-Risk Clinical Target Volume (CTV) in the Treatment of Nasopharyngeal Carcinoma.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the locoregional control, survival rate, toxicity, and quality of life in patients with nasopharyngeal carcinoma treated with reduced prophylactic irradiation doses to the Low-Risk Clinical Target Volume (CTV).

Detailed description

This phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly diagnosed, untreated, non-distant metastatic, non-keratinizing nasopharyngeal carcinoma (NPC). The intervention involves comparing reduced-dose prophylactic irradiation to standard-dose prophylactic irradiation for the low-risk clinical target volume (CTV). The objective is to compare the locoregional control, survival rate, toxicity, and quality of life between the two groups.

Conditions

• Nasopharyngeal Cancinoma (NPC)

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：42Gy/26Fr.
RADIATION	Radiation Therapy	PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：54Gy/33Fr.

Timeline

• Start date: 2025-11-17
• Primary completion: 2029-11-17
• Completion: 2031-11-17
• First posted: 2025-10-01
• Last updated: 2026-04-06

Locations

6 sites across 1 country: China