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

Recruiting now · Phase 3

Conditions studied: Nasopharyngeal Cancinoma (NPC)

In brief

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 facts

Study ID

NCT06846450

Run by

Lin Kong, MD

People needed

470

Starts

2025-04-01

Expected to finish

2031-01-31

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanghai Proton and Heavy Ion Center — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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