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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Progression-free survival — 3 years
  Progression-free survival (PFS) defined as the time interval from randomization to death or disease progression whichever comes first.

Trial sites (1)

Other trials for the same condition