NCT06846450

Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 470 (estimated)
• Sponsor: Lin Kong, MD · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this phase 3 non-inferiority trial is to compare the efficacy and toxicity of proton or photon radiation therapy plus carbon ion radiation therapy for newly diagnosed nasopharyngeal carcinoma. The main question it aims to answer is that if proton radiation therapy plus carbon ion radiation therapy is non-inferior to photon radiation therapy plus carbon ion radiation therapy in terms of therapeutic efficacy. Participants will be randomized to receive either proton radiation therapy (arm 1) or photon radiation therapy (arm 2), in addition to carbon ion radiation therapy (for both arms).

Detailed description

This is a phase 3 randomized non-inferiority trial. The primary objective of the trial is to compare progression-free survival between proton plus carbon ion radiation therapy (arm 1) and photon plus carbon ion radiation therapy (arm 2) for patients with newly diagnosed nasopharyngeal carcinoma (NPC). The secondary objectives includes overall survival, locoregional progression-free survival, distant metastasis-free survival, physician-graded toxicities according to the CTCAE, and patients-reported outcomes. This study adopts a web-based central randomization system. The randomization method uses minimization, with two balancing factors: Stage (AJCC Staging System, 9th edition): Stage I vs. Stages II/III; Response to induction chemotherapy: No induction chemotherapy vs. sensitive (CR + PR) vs. resistant (SD + PD). Eligible patients will be randomized in a 1:1 ratio into either the experimental group or the control group. This is an open-label study, meaning both patients and investigators are aware of the treatment allocation. Participants randomized to arm 1 will receive proton therapy with a dose of 56 GyRBE in 28 fractions, in addition to a boost delivered using carbon ion radiation therapy with a dose of 17.5 GyRBE in 5 fractions. Participants randomized to arm 2 will receive photon therapy with a dose of 56 Gy in 28 fractions, plus carbon ion radiation therapy with a dose of 17.5 GyRBE in 5 fractions. The treatment response will be evaluated according to the RECIST criteria. Induction chemotherapy and concurrent chemotherapy will be prescribed according to disease stage.

Conditions

• Nasopharyngeal Cancinoma (NPC)

Interventions

Type	Name	Description
RADIATION	Intensity-modulated proton radiation therapy	Intensity-modulated proton therapy, will be delivered to the high risk area with a dose of 56 GyRBE in 28 fractions, and if applicable, to the low risk area with a dose of 50.4 GyRBE in 28 fractions.
RADIATION	Intensity-modulated photon radiation therapy	Intensity-modulated photon therapy, will be delivered to the high risk area with a dose of 56 Gy in 28 fractions, and if applicable, to the low risk area with a dose of 50.4 Gy in 28 fractions.
RADIATION	Intensity-modulated carbon ion radiation therapy	Intensity-modulated carbon ion radiation therapy will be delivered as a boost with a dose of 17.5 GyRBE in 5 fractions to gross tumor.
DRUG	Concurrent chemotherapy	Concurrent chemotherapy will be administered on a weekly basis.
DRUG	Induction chemotherapy	Cisplatin-based induction chemotherapy will be administered every three weekly.

Timeline

• Start date: 2025-04-01
• Primary completion: 2031-01-31
• Completion: 2031-01-31
• First posted: 2025-02-26
• Last updated: 2025-12-02

Locations

1 site across 1 country: China