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

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 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.)

Exclusion Criteria:

Presence of distant metastatic lesions (M1). Primary squamous cell carcinoma of the head and neck not originating in the nasopharynx.

Diagnosis of types other than nasopharyngeal keratinizing carcinoma and non-keratinizing carcinoma; (Note: The inclusion criteria state WHO types: keratinizing, non-keratinizing differentiated, and undifferentiated. This exclusion seems to narrow it further or implies a nuance. This is a direct translation of the source.) Currently participating in an interventional clinical research treatment; Contraindications to radiotherapy;

Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number greater than the upper limit of normal at the respective study center's laboratory); Note: Hepatitis B subjects meeting the following criteria may also be enrolled:

HBV viral load \<1000 copies/ml (200 IU/ml) before the first dose; subjects should receive anti-HBV therapy throughout the study drug treatment period to avoid viral reactivation.

For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.

Active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); Pregnant women;

Presence of any severe or uncontrolled systemic diseases, for example:

Significant and symptomatically severe, difficult-to-control abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation\[cite: 2\]; Unstable angina, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) class ≥ 2; Any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack\[cite: 2\]; History of non-infectious pneumonitis requiring glucocorticoid therapy within 1 year prior to the first dose, or currently active interstitial lung disease; Active pulmonary tuberculosis; Active or uncontrolled infection requiring systemic therapy; Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction; Liver diseases such as severe cirrhosis, decompensated liver disease, acute or chronic active hepatitis; Patients with mental disorders who cannot cooperate with treatment; History of illness or disease, treatment, or abnormal laboratory values that could interfere with study results, hinder the subject's full participation in the study, or other situations deemed unsuitable for enrollment by the investigator; or if the investigator believes there are other potential risks making the subject unsuitable for this study

Conditions2

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