Status:
RECRUITING
PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Sahlgrenska University Hospital
The Skandion Clinic
Conditions:
Oligodendroglioma
Oligodendroglioma, Anaplastic
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 o...
Detailed Description
PRO-GLIO aims at establishing proton irradiation as standard radiotherapy for IDH-positive diffuse glioma grade II and III patients. First, PRO-GLIO will show that proton therapy is safe, despite the ...
Eligibility Criteria
Inclusion
- Patients must be 18 to 65 years old at the day of consenting
- IDH-mutated astrocytoma grade II or III, or oligodendroglioma grade II or III according to WHO 2016
- Indication for radiotherapy
- WHO/ECOG performance status 0-2
- Ability to undergo MRI
- 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.
- Ability and willingness to travel to The Skandion Clinic for proton therapy if randomized to the proton therapy arm
- 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
- Ability to understand the information about the study and included treatment and give a written informed consent
- Signed informed consent
- Ability to speak and understand Norwegian or Swedish language
Exclusion
- Prior treatment (except surgery) for diffuse glioma
- 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
- Known CDKN2A/B homozygous deletion
- Presence of any medical, psychological, familial, sociological, or geographical characteristic that might impair patient compliance for study protocol procedures including follow-up
- Body weight \> 150 kg
Key Trial Info
Start Date :
January 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2043
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT05190172
Start Date
January 14 2022
End Date
December 31 2043
Last Update
February 12 2025
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway