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Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC

RecruitingPhase 3Ages 18 Years - 70 YearsAllLin Kong, MD
NCT06846450 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this phase 3 non-inferiority trial is to compare the efficacy and toxicity of proton or photon radiation therapy plus carbon ion radiation therapy for newly diagnosed nasopharyngeal carcinoma. The main question it aims to answer is that if proton radiation therapy plus carbon ion radiation therapy is non-inferior to photon radiation therapy plus carbon ion radiation therapy in terms of therapeutic efficacy. Participants will be randomized to receive either proton radiation therapy (arm 1) or photon radiation therapy (arm 2), in addition to carbon ion radiation therapy (for both arms).

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📋 Eligibility rules (as published)
Inclusion criteria: * Willingness to sign the written informed consent. * Pathologically confirmed Nasopharyngeal carcinoma. * Patients with any stage of disease except distant metastasis. * Age: ≥ 18 and ≤ 70 years old. * Eastern Cooperative Oncology Group score: 0-1. * Adequate laboratory test results. * Willingness to accept adequate contraception. Exclusion criteria: * Presence of distant metastasis. * Previous radiotherapy to head and neck region. * Previous surgery (except for biopsy) for the primary lesion or cervical lymph nodes. * History of malignant tumor within the past 5 years. * Presence of multiple primary tumors. * Presence of diseases that may interfere with the evaluation of study endpoints. * Presence of severe major organ dysfunction. * Mental illness that may affect the understanding of informed consent.
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What it tests

  • Intensity-modulated proton radiation therapy
  • Intensity-modulated photon radiation therapy
  • Intensity-modulated carbon ion radiation therapy
  • Concurrent chemotherapy
  • Induction chemotherapy
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Where

1 site
Shanghai Proton and Heavy Ion Center
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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