NCT07000643 Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma

Trial Parameters

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief 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 Criteria

Inclusion Criteria: 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 investigat

Related Trials