RecruitingPhase 3NCT07340515

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

A Prospective, Randomized, Open-Label, Multicenter Phase III Clinical Study Comparing Intensity-Modulated Proton Therapy and Intensity-Modulated Photon Radiotherapy in Locally Advanced Nasopharyngeal Carcinoma

Sponsor

Man Hu

Enrollment

300 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Carcinoma (NPC)

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This phase III trial is directly comparing proton therapy (a precise form of radiation) versus standard photon-based radiation (IMRT) for people with locally advanced nasopharyngeal cancer — a cancer of the upper throat behind the nose. Both are given alongside chemotherapy and immunotherapy. The study aims to see whether proton therapy causes fewer long-term side effects. **You may be eligible if...** - You are 18–70 years old - You have biopsy-confirmed nasopharyngeal carcinoma (WHO type II or III) that is locally advanced (stage T4 or N3, with no distant spread) - You have not received any prior treatment for this cancer - You are in good physical condition (ECOG 0–1) with adequate organ function **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have already had treatment for nasopharyngeal cancer - You have an active autoimmune disease requiring systemic therapy - You are pregnant or breastfeeding - You have an allergy to the study medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONIntensity-Modulated Proton Therapy (IMPT)

Participants assigned to this arm receive intensity-modulated proton therapy (IMPT) according to the protocol-defined dose and fractionation schedule. Radiotherapy is delivered using the same target delineation and prescription principles as IMRT, with dose converted to Gy(RBE) for proton therapy. IMPT is administered concurrently with cisplatin-based chemotherapy and toripalimab as specified in the study protocol.

RADIATIONIntensity-Modulated Radiation Therapy (IMRT)

Participants assigned to this arm receive intensity-modulated radiation therapy (IMRT) according to the protocol-defined dose and fractionation schedule. Radiotherapy is delivered to the primary tumor and involved lymph nodes following the target delineation and prescription principles specified in the study protocol. IMRT is administered concurrently with cisplatin-based chemotherapy and toripalimab, consistent with the protocol.

DRUGCisplatin

Cisplatin is administered during induction chemotherapy and concurrent chemoradiotherapy as specified in the protocol: 80 mg/m² IV on Day 1 every 21 days for 3 cycles during induction (GP regimen), and 100 mg/m² IV on Day 1 and Day 22 for 2 cycles during concurrent chemoradiotherapy.

BIOLOGICALToripalimab

Toripalimab 240 mg is administered every 3 weeks during induction, concurrent chemoradiotherapy, and maintenance therapy for a total of 12 cycles unless disease progression or unacceptable toxicity occurs.

Locations(1)

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

Jinan, Shandong, China

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NCT07340515

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