RecruitingPhase 3NCT07000643

Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma

Proton Therapy Versus Photon Therapy for the Treatment of Nasopharyngeal Carcinoma: A Prospective, Open-Label, Multicenter, Phase III Non-Inferiority Clinical Trial

Sponsor

Man Hu

Enrollment

386 participants

Start Date

May 7, 2025

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Carcinoma

Summary

This study is a prospective, open-label, multicenter, cohort, phase III non-inferiority clinical trial comparing proton therapy with photon radiotherapy for nasopharyngeal carcinoma. It intends to enroll histologically confirmed newly diagnosed nasopharyngeal carcinoma patients without distant metastasis (M0). Through a prospective 1:1 matched cohort study design, patients will be divided into the intensity-modulated proton therapy (IMPT) group and the intensity-modulated radiation therapy (IMRT) group. Systemic treatment regimens are formulated according to clinical guidelines.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This large phase III study is comparing proton therapy (a newer type of radiation that targets tumors more precisely) to standard photon (X-ray) radiation therapy for people with nasopharyngeal carcinoma — a type of head and neck cancer — to see whether proton therapy is just as effective with fewer side effects. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with nasopharyngeal carcinoma (a cancer at the back of the nasal cavity) confirmed by biopsy - Your cancer has not spread to distant organs (no distant metastases) - You have not had prior treatment for this cancer - You are in good general health (ECOG 0–1) with adequate blood counts and organ function **You may NOT be eligible if...** - Your cancer has spread to distant sites in the body - You have had prior radiation or chemotherapy for this cancer - You have other serious health conditions that would make treatment unsafe 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 Proton Therapy (IMPT)

This is the experimental arm intervention. Patients receive Intensity-Modulated Proton Therapy (IMPT) for primary nasopharyngeal carcinoma. The subjects are patients with histologically confirmed, previously untreated, non-metastatic (M0) nasopharyngeal carcinoma. Radiotherapy target volumes and doses: GTV (gross tumor volume of primary tumor and metastatic lymph nodes); CTV70Gy (GTVp + 0-5mm margin, GTVn + 0-3mm margin, reducible near organs at risk) at a dose of 69.6-70Gy; CTV50-54Gy (GTVp + 8-10mm margin + entire nasopharyngeal mucosa + adjacent high/intermediate risk structures and intermediate-risk subclinical lymph node regions) at a dose of 50-54Gy, delivered at 2Gy/(RBE) per fraction. The protocol notes that proton therapy does not use a PTV (Planning Target Volume). The systemic therapy plan is formulated according to clinical guidelines.

RADIATIONIntensity-Modulated Radiotherapy (IMRT)

This is the control arm intervention. Patients receive Intensity-Modulated Radiotherapy (IMRT) for primary nasopharyngeal carcinoma; IMRT is one of the current standard and widely used treatment techniques. The subjects are patients with histologically confirmed, previously untreated, non-metastatic (M0) nasopharyngeal carcinoma. Radiotherapy target volumes and doses: GTV (gross tumor volume of primary tumor and metastatic lymph nodes); CTV70Gy (GTVp + 0-5mm margin, GTVn + 0-3mm margin); PTV70 (CTV70 + 3-5mm margin, reducible near organs at risk) at a dose of 70Gy; CTV50-54Gy (GTVp + 8-10mm margin + entire nasopharyngeal mucosa + adjacent high/intermediate risk structures and intermediate-risk subclinical lymph node regions); PTV50-54 (CTV50-54 + 3-5mm margin, reducible near organs at risk) at a dose of 50-54Gy, delivered at 2Gy/(RBE) per fraction. The systemic therapy plan is formulated according to clinical guidelines.

Locations(1)

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

Jinan, China

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