New study tests if proton radiation can spare brain tissue without hurting survival
NCT ID NCT05190172
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares proton therapy to standard photon radiation for people with slow-growing brain tumors (IDH-mutated gliomas). The goal is to see if proton therapy, which targets tumors more precisely, can reduce side effects and maintain quality of life without shortening survival. About 225 adults aged 18-65 will take part, and researchers will track survival, fatigue, and thinking skills for two years after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation therapy (proton or photon)
- What this could lead to
- If proton therapy works as well as standard photon therapy, it could reduce side effects and improve quality of life for people with certain brain tumors.
- What could go wrong
- This is a mid-stage trial with 225 participants, so results are not final. Proton therapy might not be as effective at controlling the tumor, and long-term survival data are still being collected.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 225 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Dec 2045
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Oslo University Hospital
RECRUITINGOslo, Norway
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