RecruitingPhase 3NCT06752239

Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC

Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in Nasopharyngeal Carcinoma (PROTECT-NPC): A Multicenter, Non-Inferiority, Open-Label, Randomized Controlled Phase III Clinical Trial

Sponsor

Jiangxi Provincial Cancer Hospital

Enrollment

474 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Radiotherapy Side Effect Quality of Life Radiotherapy Nasopharyngeal Carcinoma Thyroid Diseases

Summary

This study is a multicenter, non-inferiority, open-label, randomized controlled Phase III clinical trial. It aims to compare the efficacy of modified delineation radiotherapy (experimental group) versus standard delineation radiotherapy (control group) in the prophylactic irradiation of neck lymphatic drainage areas III/IVa in nasopharyngeal carcinoma. The study evaluates the incidence of primary hypothyroidism, quality of life, and adverse events between the two groups.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether reducing the radiation field to the thyroid area during treatment for nasopharyngeal cancer (a cancer in the back of the nose/throat) can protect thyroid function without compromising cancer control. **You may be eligible if...** - You are 18–70 years old - You have been diagnosed with nasopharyngeal carcinoma (confirmed by pathology) - You have no sign of cancer spread to distant organs - Your thyroid function is normal - You are in good health (ECOG 0–1) and have not received any prior cancer treatment - Your blood counts and organ function are within required ranges **You may NOT be eligible if...** - You have had another cancer (other than minor skin cancers or cervical carcinoma in situ) - You have previously had radiation therapy or neck surgery - You have unstable heart disease or other severe health conditions 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

RADIATIONModified delineation

Modified delineation (MD) of cervical lymphatic drainage areas, sparing the common carotid artery within the clinical target volume (CTV)

RADIATIONStandard delineation

Standard delineation

Locations(1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

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NCT06752239

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