Proton vs Photon IMRT in Locally Advanced Nasopharyngeal Carcinoma: A Phase III Trial

This multicenter, open-label, randomized Phase III trial evaluates intensity-modulated proton therapy (IMPT) versus intensity-modulated photon radiotherapy (IMRT) in patients with newly diagnosed, high-risk, locoregionally advanced nasopharyngeal carcinoma. All patients receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy and are randomized 1:1 to IMPT or IMRT during the concurrent treatment phase. The primary endpoints are the incidence of grade ≥3 acute treatment-related toxicities and the 3-year progression-free survival (PFS) rate. Secondary

Trial Details

NCT ID
NCT07340515
Phase
PHASE3
Sponsor
Man Hu
Status
RECRUITING
Cancer Type
Nasopharyngeal Head and Neck Cancer
Interventions
  • Intensity-Modulated Proton Therapy (IMPT)
  • Intensity-Modulated Radiation Therapy (IMRT)
  • Cisplatin
  • Toripalimab
Locations (sample)
  • Jinan, Shandong, China|36.66833,116.99722

Key Eligibility Criteria

  • Age 18 to 70 years
  • Histologically confirmed nasopharyngeal carcinoma (WHO type II or III)
  • High-risk locoregionally advanced disease defined as clinical stage T4 or N3, M0, according to the AJCC staging system
  • No prior anti-tumor therapy for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy

For full eligibility, visit ClinicalTrials.gov.

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