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

NCT06846450 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2025-12-02

No results posted yet for this study

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).

Conditions

  • Nasopharyngeal Cancinoma (NPC)

Interventions

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.

Sponsors & Collaborators

  • Lin Kong, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2031-01-31
Completion
2031-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06846450 on ClinicalTrials.gov