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

RecruitingPhase 3Ages 18 Years - 70 YearsAllMan Hu
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ3 acute treatment-related toxicities and the 3-year progression-free survival (PFS) rate. Secondary endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, objective response rate, late toxicities, and quality of life.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion 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 * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Adequate organ function as defined in the study protocol * Eligible to receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy as specified in the protocol * Ability to understand and willingness to sign written informed consent Exclusion Criteria: * Evidence of distant metastasis (M1 disease) * Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy for nasopharyngeal carcinoma * Active autoimmune disease requiring systemic therapy * Uncontrolled infection or severe comorbidities that may affect treatment tolerance * Pregnancy or breastfeeding * Known allergy, hypersensitivity, or contraindication to study medications as defined in the protocol * Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation
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What it tests

  • Intensity-Modulated Proton Therapy (IMPT)
  • Intensity-Modulated Radiation Therapy (IMRT)
  • Cisplatin
  • Toripalimab
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Where

1 site
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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