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

Recruiting now · Phase 3

Conditions studied: Nasopharyngeal Carcinoma (NPC)

In brief

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.

Key facts

Study ID

NCT07340515

Run by

Man Hu

People needed

300

Starts

2025-12-15

Expected to finish

2031-12-31

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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