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Compares treatment options for Oligodendroglioma
Official title PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas
ClinicalTrials.gov ID: NCT05190172
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Patients must be 18 to 65 years old on the day of consent.
- IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3 according to WHO 2021.
- Indication for radiotherapy.
- WHO/ECOG performance status 0-2.
- Ability to undergo MRI.
You likely can't join if
- 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...
- Known CDKN2A/B homozygous deletion
- Presence of any medical, psychological, familial, sociological, or geographical characteristic that might impair patient compliance for study...
- Body weight \> 150 kg
See the full eligibility criteria
- Patients must be 18 to 65 years old on the day of consent.
- IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3 according to WHO 2021.
- Indication for radiotherapy.
- WHO/ECOG performance status 0-2.
- Ability to undergo MRI.
- 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...
- Ability and willingness to travel to a proton therapy centre if assigned by chance 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...
- Ability to understand the information about the study and included treatment.
- Signed informed consent.
- Ability to speak and understand Norwegian or Swedish language.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.