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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Signed written informed consent prior to the implementation of any trial-related procedures; No gender restriction, age ≥18 years and ≤75 years; Histologically confirmed, according to the latest WHO classification, including keratinizing carcinoma, non-keratinizing differentiated carcinoma, and undifferentiated carcinoma; Investigator-assessed nasopharyngeal carcinoma (cT1-4N0-3M0, AJCC 9th Edition); No prior systemic anti-tumor therapy for locally advanced disease; ECOG performance status 0-1;

• Adequate organ function, subjects must meet the following laboratory parameters:

• Absolute neutrophil count (ANC) ≥1.5x10⁹/L. Platelets ≥75×10⁹/L. Hemoglobin ≥9 g/dL (90 g/L) or ≥5.6 mmol/L; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5×ULN (Upper Limit of Normal) Serum creatinine ≤1.5×ULN AND creatinine clearance (calculated using Cockcroft-Gault formula) ≥60 ml/min; Good coagulation function: simple laboratory abnormalities judged by the investigator to be without clinical significance; Myocardial enzyme spectrum: simple laboratory abnormalities judged by the investigator to be without clinical significance; (Note: The document lists this as criteria 8 under 3.2.1 in the main text, but the synopsis table formatting places it slightly differently though it appears to be the last point of item 7 in structure. For clarity, listing as a separate main point as per the detailed protocol structure.)

Locations
Other Locations
China
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
RECRUITING
Jinan
Contact Information
Primary
Man Hu, Dr
mhu@sdfmu.edu
86-053167626152
Backup
Wanqi Zhu, Dr
sdszlyy@163.com
86-67626624
Time Frame
Start Date: 2025-05-07
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 386
Treatments
Experimental: IMPT Group
Patients in this group will receive Intensity-Modulated Proton Therapy (IMPT). The systemic therapy plan will be formulated according to clinical guidelines. These patients have histologically confirmed, previously untreated, non-metastatic (M0) nasopharyngeal carcinoma.
Other: IMRT Group
Patients in this group will receive Intensity-Modulated Radiotherapy (IMRT). IMRT is currently one of the most widely used techniques and serves as a standard treatment. The systemic therapy plan will be formulated according to clinical guidelines. These patients have histologically confirmed, previously untreated, non-metastatic (M0) nasopharyngeal carcinoma.
Related Therapeutic Areas
Sponsors
Leads: Man Hu

This content was sourced from clinicaltrials.gov

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