Actively Recruiting
Led by Oslo University Hospital · Updated on 2026-05-01
225
Participants Needed
1
Research Sites
782 weeks
Total Duration
O
Oslo University Hospital
Lead Sponsor
S
Sahlgrenska University Hospital
Collaborating Sponsor
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.
CONDITIONS
PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of radiation therapy as per individual treatment plan
Participants receive radiation therapy either with protons or photons as part of their assigned treatment group.
Multiple visits for radiation therapy sessions
Duration - Up to 15 years after treatment
Participants are monitored for survival, cognitive function, fatigue, neurological function, adverse events, and quality of life over several years after treatment.
Scheduled visits at 6 weeks, 3 months, 5 months, 1 year, 2, 5, 10, and 15 years post-treatment
Total: 1 location
1
Oslo University Hospital
Oslo, Norway
Actively Recruiting
P
Petter Brandal, MD PhD
D
Danielle Hagen
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Liv Cathrine Heggebø, Ida Maria Henriksen Borgen, Hillevi Rylander...
https://pubmed.ncbi.nlm.nih.gov/36940951