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

Trial ID: NCT05190172

Interventional - Phase Unknown - Recruiting

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

• Oligodendroglioma
• Oligodendroglioma, Anaplastic
• Diffuse Astrocytoma, IDH-Mutant

Interventions

• Radiation therapy

Eligibility

Inclusion criteria

• 1. Patients must be 18 to 65 years old on the day of consent.
• 2. IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3 according to WHO 2021.
• 3. Indication for radiotherapy.
• 4. WHO/ECOG performance status 0-2.
• 5. Ability to undergo MRI.
• 6. No significant contrast enhancing tumour (more than 1 or 2 punctate contrast enhancing foci) at the time of randomization. In recurrence patients, no contrast enhancement is allowed unless a new biopsy confirms the diagnosis of IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3.
• 7. Ability and willingness to travel to a proton therapy centre if randomized to the proton therapy arm.
• 8. Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception during radiotherapy, chemotherapy and 1 year after completion of chemotherapy. Pregnancy is not an ineligibility criterium if radiotherapy is indicated and cannot be postponed
• 9. Ability to understand the information about the study and included treatment.
• 10. Signed informed consent.
• 11. Ability to speak and understand Norwegian or Swedish language.

Exclusion criteria

• 1. Prior treatment (except surgery) for diffuse glioma
• 2. Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years
• 3. Known CDKN2A/B homozygous deletion
• 4. Presence of any medical, psychological, familial, sociological, or geographical characteristic that might impair patient compliance for study protocol procedures including follow-up
• 5. Body weight \> 150 kg

Sponsor

Oslo University Hospital, Sahlgrenska University Hospital, The Skandion Clinic, University Hospital of North Norway, St. Olavs Hospital, Haukeland University Hospital, Lund University Hospital, Ôrebro University Hospital, Uppsala University Hospital, Karolinska University Hospital, University Hospital, Umeå, University Hospital, Linkoeping, Ryhov County Hospital

Source: ClinicalTrials.gov

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