NCT05519956

Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines

Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines: an Open-label, Non-inferiority, Multicentre, Randomised Phase 3 Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 398 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Currently, nasopharyngeal carcinoma (NPC) patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II will be recommended to receive level Ib-covering IMRT according to the International Guidelines. Our previous study, which retrospectively analyzed a cohort of 390 patients, indicated that it should be safe and feasible for patients who only had at least one of the above two radiological features. Thus, the investigators conduct this non-inferior phase 3, randomized trial to further determine the feasibility of sparing level Ib in patients who had level II involvement with ECE, and/or had a MAD of greater than 2cm in level II.

Detailed description

Currently, nasopharyngeal carcinoma (NPC) patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II will be recommended to receive level Ib-covering IMRT according to the International Guidelines. Our previous study, which retrospectively analyzed a cohort of 390 patients, indicated that it should be safe and feasible for patients who only had at least one of the above two radiological features. Thus, the investigators conduct this non-inferior phase 3, randomized trial to further determine the feasibility of sparing level Ib in patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
RADIATION	level Ib-covering IMRT	Patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II.
RADIATION	level Ib-sparing IMRT	Patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II.

Timeline

• Start date: 2022-09-16
• Primary completion: 2025-09-01
• Completion: 2025-09-30
• First posted: 2022-08-29
• Last updated: 2022-09-19