NCT06095154

CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma

CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma: A Prospective, Multi-center, Randomized Controlled Phase III Clinical Study

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

Summary

This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The aim of this study is to evaluate the efficacy and safety of modified IMRT, of which CTV delineation was only based on geometric expansion from GTV.

Detailed description

All enrolled patients underwent intensity-modulated radiation therapy (IMRT). The IMRT technique was selected based on the equipment available at each treatment center and the patients' preferences, including IMRT, VMAT, or TOMOTHERAPY. According to our study design, all enrolled patients will be randomly assigned in a 1:1 ratio before radiation therapy. The target area definitions are based on the international ICRU reports No. 50 and No. 60. The specific target area definitions and prescribed doses for the two groups are as follows: 1. GTVp (70Gy/33Fx) Experimental Group: Gross tumor as seen on imaging and nasopharyngoscopy; Control Group: Gross tumor as seen on imaging and nasopharyngoscopy. 2. CTVp1 (60Gy/33Fx) Experimental Group: None; Control Group: GTVp + 5 mm + entire nasopharyngeal mucosa. 3. CTVp2 (54Gy/33Fx) Experimental Group: GTVp + 10 mm + entire nasopharyngeal mucosa; Control Group: GTVp + 10 mm + high-risk anatomical structures. 4. GTVn Experimental Group: Lymph nodes as seen on imaging; Control Group: Lymph nodes as seen on imaging. 5. CTVn Experimental Group: Defined according to CACA/CMDA guidelines; Control Group: Defined according to CACA/CMDA guidelines.

Conditions

• Nasopharyngeal Carcinoma by AJCC V8 Stage

Interventions

Type	Name	Description
RADIATION	CTV Delineation Based on Geometric Expansion From GTV in Nasopharyngeal Carcinoma	CTVp2 is generated by expanding GTVp by 10 mm and including the nasopharyngeal mucosa.

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-12-31
• Completion: 2030-12-31
• First posted: 2023-10-23
• Last updated: 2025-03-13

Locations

1 site across 1 country: China