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RECRUITING
NCT05780372
PHASE3

Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

474

Start Date

2023-08-08

Completion Date

2028-05

Last Updated

2025-01-28

Healthy Volunteers

No

Interventions

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.

Locations (7)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Dongguan People Hospital

Dongguan, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Liuzhou Worker's Hospital

Liuchow, Guangxi, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Jiangxi Cancer Hospital of Nanchang University

Nanchang, Jiangxi, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China