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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLin Kong, MD

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Intensity-modulated proton radiation therapy
  • Intensity-modulated photon radiation therapy
  • Intensity-modulated carbon ion radiation therapy
  • Concurrent chemotherapy
  • Induction chemotherapy

Treatment groups

470 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Lin Kong, MD

Lead sponsor

Shanghai Proton and Heavy Ion Center

Sponsor institution