Actively Recruiting
PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas
Led by Oslo University Hospital · Updated on 2026-05-01
225
Participants Needed
1
Research Sites
1250 weeks
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
S
Sahlgrenska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Proton therapy is a powerful tool enabling oncologists to spare normal tissue around the target for irradiation much better than what can be achieved with photon irradiation. The infiltrative nature of IDH-mutated grade II and III diffuse glioma, however, renders proton therapy a potential problem. A randomized controlled trial (RCT) is the only option when trying to ensure that chances of long-term survival are not impaired seeking to reduce unwanted late treatment effects. Non-inferiority of proton therapy compared to photon irradiation is the primary endpoint of the RCT. Hence, PRO-GLIO has two main objectives. First, PRO-GLIO will evaluate if proton therapy is safe in patients with IDH-mutated grade II and III diffuse glioma, showing that survival figures at 2 years from radiotherapy are not poorer in the proton arm than in the photon arm. Second, we want to find the true number of patients in need of rehabilitation in both arms, and evaluate if proton therapy conveys a higher QoL than photon irradiation at 2 years from radiotherapy.
CONDITIONS
Official Title
PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 to 65 years old on the day of consent.
- Diagnosis of grade II or III IDH-mutated astrocytoma or oligodendroglioma according to WHO 2021.
- Indication for radiotherapy.
- WHO/ECOG performance status of 0 to 2.
- Ability to undergo MRI.
- No significant contrast-enhancing tumor at randomization; in recurrence, no contrast enhancement unless biopsy confirms diagnosis.
- Ability and willingness to travel to a proton therapy center if randomized to proton therapy.
- Women of child-bearing potential must agree to use effective contraception during radiotherapy, chemotherapy, and for 1 year after chemotherapy.
- Ability to understand study information and treatment.
- Signed informed consent.
- Ability to speak and understand Norwegian or Swedish.
You will not qualify if you...
- Prior treatments for diffuse glioma other than surgery.
- Concomitant or previous malignancies, except certain treated skin cancers or in situ cervical carcinoma with sufficient follow-up, or other malignancies with at least 5 years disease-free interval.
- Known CDKN2A/B homozygous deletion.
- Any medical, psychological, familial, sociological, or geographical factors impairing compliance with study procedures including follow-up.
- Body weight over 150 kg.
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway
Actively Recruiting
Research Team
P
Petter Brandal, MD PhD
CONTACT
D
Danielle Hagen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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