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

Summary

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 endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, objective response rate, late toxicities, and quality of life.

Eligibility

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

Conditions2

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