OncoMatch/Clinical Trials/NCT07000643
Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma
Is NCT07000643 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for nasopharyngeal carcinoma.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage CT1-4N0-3M0 (AJCC 9th Edition)
Investigator-assessed nasopharyngeal carcinoma (cT1-4N0-3M0, AJCC 9th Edition); Presence of distant metastatic lesions (M1) [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-tumor therapy
Lab requirements
Blood counts
ANC ≥1.5x10⁹/L; Platelets ≥75×10⁹/L; Hemoglobin ≥9 g/dL (90 g/L) or ≥5.6 mmol/L
Kidney function
Serum creatinine ≤1.5×ULN AND creatinine clearance (Cockcroft-Gault) ≥60 ml/min
Liver function
AST and ALT ≤2.5×ULN
Cardiac function
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
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;
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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