Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

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.

Conditions

• Nasopharyngeal Carcinoma
• Radiotherapy; Complications

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.

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Chongqing University Cancer Hospital

  collaborator OTHER

• Dongguan People's Hospital

  collaborator OTHER_GOV

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• The First Affiliate Hospital of Guangxi Medical College

  collaborator UNKNOWN

• Liuzhou Workers' Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Wuzhou Red Cross Hospital

  collaborator OTHER

• Hubei Cancer Hospital

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Chong Zhao, MD PhD · Sun Yat-Sen University Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-08

Primary Completion

2025-04-01

Completion

2028-04-30

Countries

• China

Study Locations