RecruitingPhase 3NCT05780372

Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma

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

Sponsor

Sun Yat-sen University

Enrollment

474 participants

Start Date

Aug 8, 2023

Study Type

INTERVENTIONAL

Conditions

Radiotherapy; Complications 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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a smaller area of neck irradiation (radiation therapy) is just as effective as the standard larger-field approach in treating nasopharyngeal carcinoma (a cancer at the back of the nose and throat). The aim is to reduce side effects without compromising the effectiveness of treatment. **You may be eligible if:** - You have a new confirmed diagnosis of nasopharyngeal non-keratinizing carcinoma (a specific type of throat cancer) - You are between 18 and 70 years old - Your cancer is at stage I–IVa and has not spread to distant organs - Your general health is good (ECOG score 0–1) - You have not previously received radiation, chemotherapy, or other cancer treatments - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if:** - You have already received radiation or chemotherapy - You have spread of cancer beyond the head and neck region - You have serious health conditions that prevent standard cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONIntensity 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).

DRUGChemotherapy

Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.