NCT06912698

Reduced Dose Radiotherapy vs Standard Dose Radiotherapy for Early Stage Nasopharyngeal Carcinoma

A Phase III Randomized Controlled Non-Inferiority Clinical Trial Comparing Reduced-Dose Versus Standard-Dose Radiotherapy Based on Treatment Response in Early-Stage Nasopharyngeal Carcinoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (estimated)
• Sponsor: Hai-Qiang Mai,MD,PhD · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy.

Detailed description

All the patients receive intensity-modulated radiotherapy. If patients receive CR and EBV DNA undetectable when completing 50.88Gy radiation, they will continue to receive radiotherapy until 61.48Gy, then the patients would be randomised assigned ( 1:1 ) to reduced dose group (observation) or standard dose group (continue to receive radiotherapy until 69.96Gy). Patients with stage IA will receive radiotherapy alone, and patients with stage IB will receive concurrent chemoradiotherapy. For patients with stage IB, those assigned to reduced dose group will receive a total of 2 cycles cisplatin concurrent chemotherapy, with 100mg/m2 per cycle; those assigned to standard dose group will receive a total of 3 cycles cisplatin concurrent chemotherapy, with 100mg/m2 per cycle. This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy. The primary endpoint is 3-year locoregional relapse-free survival.

Conditions

• Nasopharyngeal Cancinoma (NPC)

Interventions

Type	Name	Description
RADIATION	Reduced dose radiation	Reduced dose group would receive 61.48Gy radiation.
RADIATION	Standard dose radiation	Standard dose group would receive 69.96Gy radiation.

Timeline

• Start date: 2025-05-22
• Primary completion: 2031-04-19
• Completion: 2033-03-19
• First posted: 2025-04-06
• Last updated: 2025-04-22

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study