PRO-GLIO Trial Comparing Proton and Photon Radiation Therapy for Adults with IDH-Mutated Grade II and III Diffuse Gliomas

What this Trial Is About

Researchers are evaluating proton therapy compared to photon irradiation for patients with IDH-mutated grade II and III diffuse glioma. This study aims to determine if proton therapy is as safe as photon therapy in terms of survival at 2 years after radiotherapy, while also assessing quality of life and rehabilitation needs. The trial focuses on reducing unwanted late treatment effects without impairing long-term survival. Participants will be randomly assigned to receive either proton or photon radiation therapy. The study is divided into three parts survival outcomes and quality-adjusted life years QALY analysis, cognitive function testing using internet-based and in-depth neuropsychological assessments, and patient-reported outcome measures to identify challenges faced by this patient group. Treatment is delivered at specialized centers, and patients in the proton therapy group must be willing to travel to a proton therapy center. During the study, participants will undergo regular assessments including survival data, cognitive tests, fatigue questionnaires, neurological function scales, and quality of life evaluations over periods up to 15 years. Researchers will monitor adverse events, seizure rates, tumor recurrence, and economic impacts. The primary outcome is intervention-free survival at 2 years, with ongoing follow-up extending well beyond this time to capture long-term effects and patient-reported outcomes.

PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas