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

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Proton and Heavy Ion Center
RECRUITING
Shanghai
Contact Information
Primary
Lin Kong
konglinjiang@163.com
86-38296666
Backup
Jiyi Hu
jiyi.hu@sphic.org.cn
86-38296666
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2031-01-31
Participants
Target number of participants: 470
Treatments
Experimental: Arm 1
Active_comparator: Arm 2
Related Therapeutic Areas
Sponsors
Leads: Lin Kong, MD

This content was sourced from clinicaltrials.gov

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