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

Condition(s) studied

Investigational drug(s) / intervention(s)

Intensity-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.

Intensity-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.

Cisplatin: 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.

Toripalimab: 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.

Study 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

Primary outcome measure(s)

• Incidence of treatment-related grade ≥3 acute toxicities — From the start of radiotherapy to 90 days after completion of radiotherapy
  The proportion of patients who experience treatment-related grade ≥3 acute toxicities, defined as adverse events occurring from the start of radiotherapy to 90 days after completion of radiotherapy, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and Radiation Therapy Oncology Group (RTOG) criteria. Ototoxicity (hearing loss or tinnitus), if present, will additionally be evaluated using the American Speech-Language-Hearing Association (ASHA, 1994) significant change criteria.
• 3-year Progression-Free Survival (PFS) Rate — 3 years
  Defined as the proportion of participants who remain alive and progression-free at 3 years after randomization, with progression-free survival events defined as disease progression or death from any cause, whichever occurs first.

Trial sites (1)

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