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

Launched by OSLO UNIVERSITY HOSPITAL · Jan 12, 2022

Keywords

ClinConnect Summary

The PRO-GLIO trial is studying the use of two different types of radiation therapy—proton therapy and photon therapy—for patients with certain types of brain tumors called IDH-mutated diffuse gliomas, specifically grade II and III oligodendrogliomas and astrocytomas. The main goal is to find out if proton therapy is just as safe and effective as photon therapy, while also checking if it leads to fewer long-term side effects and a better quality of life two years after treatment.

To be eligible for this study, participants need to be between 18 and 65 years old, must have a diagnosis of the specified types of brain tumors, and require radiation treatment. They should also be able to travel to The Skandion Clinic for proton therapy if chosen for that treatment. Participants will undergo regular check-ups and assessments to monitor their health and recovery during the study. This trial is currently recruiting, so interested patients can learn more about how to get involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must be 18 to 65 years old at the day of consenting
• • 2. IDH-mutated astrocytoma grade II or III, or oligodendroglioma grade II or III according to WHO 2016
• • 3. Indication for radiotherapy
• • 4. WHO/ECOG performance status 0-2
• • 5. Ability to undergo MRI
• • 6. No significant contrast enhancing tumor (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 The Skandion Clinic for proton therapy 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 and give a written informed consent
• • 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