Proton versus photon radiation for advanced nasopharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, randomized Phase III trial enrolling adults with newly diagnosed, high‑risk locoregionally advanced nasopharyngeal carcinoma (WHO type II/III, clinical T4 or N3, M0). All participants receive three cycles of induction chemotherapy with gemcitabine plus cisplatin, then concurrent chemoradiotherapy combined with immunotherapy, during which they are randomized 1:1 to receive either intensity-modulated proton therapy (IMPT) or intensity-modulated photon radiotherapy (IMRT). The co-primary endpoints are the incidence of grade ≥3 acute treatment-related toxicities and 3-year progression-free survival, with secondary endpoints including overall survival, locoregional relapse-free survival, distant metastasis-free survival, objective response rate, late toxicities, and quality of life. Toxicities are graded by CTCAE v5.0 (with specific ototoxicity measures), and radiotherapy is delivered per protocol-defined target delineation, dose, and fractionation schedules.

Why it matters

Who can join: the full rules

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

Where it's running

• Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
  Jinan, Shandong, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.