RecruitingPhase 3NCT06846450

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

Sponsor

Lin Kong, MD

Enrollment

470 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Cancinoma (NPC)

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).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

Willingness to sign the written informed consent.
Pathologically confirmed Nasopharyngeal carcinoma.
Patients with any stage of disease except distant metastasis.
Age: ≥ 18 and ≤ 70 years old.
Eastern Cooperative Oncology Group score: 0-1.
Adequate laboratory test results.
Willingness to accept adequate contraception.

Exclusion Criteria8

Presence of distant metastasis.
Previous radiotherapy to head and neck region.
Previous surgery (except for biopsy) for the primary lesion or cervical lymph nodes.
History of malignant tumor within the past 5 years.
Presence of multiple primary tumors.
Presence of diseases that may interfere with the evaluation of study endpoints.
Presence of severe major organ dysfunction.
Mental illness that may affect the understanding of informed consent.

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Interventions

RADIATIONIntensity-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.

RADIATIONIntensity-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.

RADIATIONIntensity-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.

DRUGConcurrent chemotherapy

Concurrent chemotherapy will be administered on a weekly basis.

DRUGInduction chemotherapy

Cisplatin-based induction chemotherapy will be administered every three weekly.