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

ConditionNasopharyngeal Carcinoma (NPC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMan Hu

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intensity-Modulated Proton Therapy (IMPT)

    Radiation

    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)

    Radiation

    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

    Drug

    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

    Biological/Vaccine

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: IMPT ArmExperimental treatment 3 interventions
Group B: IMRT ArmActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of treatment-related grade ≥3 acute toxicities

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.

Time frame
From the start of radiotherapy to 90 days after completion of radiotherapy
2

3-year Progression-Free Survival (PFS) Rate

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.

Time frame
3 years

Secondary outcomes

1

Overall Survival (OS)

Defined as the time interval from randomization to death due to any cause.

Time frame
3 years
2

Locoregional Recurrence-Free Survival (LRRFS)

Defined as the time from randomization to the date of first locoregional relapse.

Time frame
3 years
3

Distant Metastasis-Free Survival (DMFS)

Defined as the time interval from randomization to the date of first distant metastasis.

Time frame
3 years
4

Objective Response Rate (ORR)

Defined as the proportion of participants who achieve a complete response (CR) or partial response (PR). Tumor response will be evaluated 2 weeks after completion of induction chemotherapy and 3 months after completion of radiotherapy.

Time frame
2 weeks after induction chemotherapy and 3 months after completion of radiotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Man Hu

Lead sponsor

Shandong Cancer Hospital and Institute

Sponsor institution

Shandong Cancer Hospital and Institute

Collaborator

Source ClinicalTrials.gov
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