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Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC
Sponsor: Lin Kong, MD
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).
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
470
Start Date
2025-04-01
Completion Date
2031-01-31
Last Updated
2025-12-02
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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.
Concurrent chemotherapy
Concurrent chemotherapy will be administered on a weekly basis.
Induction chemotherapy
Cisplatin-based induction chemotherapy will be administered every three weekly.
Locations (1)
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China