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

Trial Details

NCT ID
NCT07000643
Phase
PHASE3
Sponsor
Man Hu
Status
RECRUITING
Cancer Type
Nasopharyngeal Head and Neck Cancer
Interventions
  • Intensity-Modulated Proton Therapy (IMPT)
  • Intensity-Modulated Radiotherapy (IMRT)
Locations (sample)
  • Jinan, China|36.66833,116.99722

Key Eligibility Criteria

  • Signed written informed consent prior to the implementation of any trial-related procedures; No gender restriction, age ≥18 years and ≤75 years; Hi…
  • 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 A…

For full eligibility, visit ClinicalTrials.gov.

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