RecruitingPhase 3NCT07303023

Individualized Neck Cervical Irradiation Prophylaxis Trial of NPC

Individualized Versus Standard Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: A Non-inferiority, Phase III, Multicenter, Prospective, Randomized Controlled Trial


Sponsor

Fudan University

Enrollment

462 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Based on the pattern of nasopharyngeal carcinoma cervical lymph node metastasis, which typically follows a sequential downward spread with rare skip metastases and a tendency for ipsilateral neck involvement, and in accordance with the latest international guidelines, we propose the following scientific hypothesis: individualized neck prophylactic irradiation for nasopharyngeal carcinoma based on the superior-to-inferior extent of metastatic lymph nodes is feasible. Specifically: if there is no lymph node metastasis, irradiation need only extend to the lower border of Level II; if there are suspected metastatic lymph nodes, a prophylactic dose of 55-60 Gy should be administered; the investigational arm will only require irradiation extending to 3 cm below the lowest level of metastatic (including suspected) lymph nodes in each neck.This study will prospectively enroll patients with N0-N3 stage nasopharyngeal carcinoma and randomize them to compare individualized neck irradiation based on the vertebral body level of metastatic lymph nodes versus selective upper neck prophylactic irradiation. The primary endpoint is neck recurrence-free survival. Secondary endpoints include overall survival, local recurrence-free survival and other survival data, incidence of acute and late neck radiation-induced injuries, and quality of life, aiming to validate the feasibility of individualized neck irradiation based on metastatic patterns.Photon IMRT and photon plus carbon-ion radiotherapy will serve as stratification factors, enabling further comparison of local control and toxicity between photon-carbon-ion therapy and photon-only (or proton) therapy. This study seeks to protect critical structures such as the thyroid, trachea, esophagus, and neck muscles while maintaining therapeutic efficacy, ultimately improving the quality of life for nasopharyngeal carcinoma patients.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether reducing the area of the neck that is treated with radiation (prophylactic neck irradiation) during treatment for nasopharyngeal carcinoma (a cancer at the back of the nasal cavity) can reduce side effects without compromising cancer control. Researchers want to see if a more targeted, individualized approach to neck radiation is as effective as the current standard. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with nasopharyngeal carcinoma (confirmed by pathology) - Your cancer is staged as I–III (T1–T4, N0–N3, M0) with no distant spread confirmed by PET/CT or other scans - You are able to have an MRI scan - Your blood counts and organ function meet the required levels for radiation treatment **You may NOT be eligible if...** - You have distant metastases (cancer spread to other organs) - Your blood counts or organ function are insufficient - You are pregnant or breastfeeding 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

RADIATIONIndividualized Neck Irradiation

After confirmation of the radiotherapy technique, patients will be randomized. Patients in the investigational arm will receive bilateral upper neck irradiation covering at least Level II. If cervical lymph nodes are positive, the clinical target volume (CTV) will extend to 3 cm below the lowest level of metastatic (including suspected) lymph nodes.

RADIATIONStandard Neck Irradiation

Patients in the control arm will receive bilateral upper neck irradiation to level III; if upper neck nodes are positive, prophylactic irradiation of the lower neck will be performed.


Locations(6)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Eye, Ear, Nose and Throat Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Sichuan Cancer Hospital & Institute

Chengdu, China

Chongqing Cancer Hospital

Chongqing, China

Shanghai Proton and Heavy Ion Center

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT07303023


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