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

NCT07000643 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2025-06-03

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

RADIATION

Intensity-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.

RADIATION

Intensity-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.

Sponsors & Collaborators

  • Man Hu

    lead OTHER

Principal Investigators

  • Man Hu, Dr · Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2027-02-28
Completion
2029-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07000643 on ClinicalTrials.gov