Can a sharper beam of radiation shield the mind during brain tumor treatment?
NCT ID NCT07750457
First seen Aug 06, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This trial is testing whether proton therapy, a more precise form of radiation, can better preserve memory and thinking skills compared to standard photon radiation in people with slow-growing brain tumors (grade 2 or 3 gliomas). Participants will be randomly assigned to receive either proton or photon radiation, and their cognitive function will be tracked for several years. The goal is to see if the more targeted approach reduces damage to healthy brain tissue and helps maintain quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton therapy (a type of radiation that may spare healthy brain tissue) compared to standard photon radiation therapy
- What this could lead to
- If proton therapy better preserves thinking and memory after brain radiation, it could become a preferred treatment option for people with low-grade gliomas.
- What could go wrong
- This is a relatively small study, and the benefit is not guaranteed. Proton therapy may not significantly improve cognitive outcomes, and there are always risks from radiation itself.
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 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2019
- Expected to finish
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Dec 2033
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 years and older
- 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.
Inclusion Criteria: * 1\. Histologically confirmed IDH-mutated WHO Grade 2 or 3 glioma with an indication for radiation therapy as determined by the local tumorboard at the study center * 2\. Tumor classification according to the 2021 WHO Classification, including the presence of the following markers: * IDH1/2 mutation * ATRX and/or 1p19q codeletion status * CDKN2A/B codeletion status * 3\. A Karnofsky Performance Status of ≥ 70% * 4\. Patients must be ≥ 18 years of age * 5\. Radiation therapy must begin within 7 weeks of surgery in patients with CNS WHO Grade 2 IDH-mutated gliomas. In individual cases, the start may be delayed, but not later than 10 weeks after surgery * 6\. For patients with WHO Grade 2 IDH-mutated CNS gliomas, the following applies: * There is an indication for radiation therapy (partial tumor resection, age \> 40 years, relevant neurological deficit) * Enrollment in the study at the time of tumor progression is possible, even without a time constraint relative to the initial surgery, if the following criteria are met: * There was initially no indication for radiation therapy * At the time of tumor progression, there is an indication for radiation therapy as determined by the local tumor board * At the time of recurrence, no repeat surgery is required to confirm the diagnosis if there is no imaging evidence of malignancy (see exclusion criterion No. 4) * Radiation therapy must begin within 7 weeks after the recurrence MRI (or surgery, if a repeat surgery has been performed). In individual cases, treatment may begin later, but no later than 10 weeks after the recurrence MRI/surgery * 7\. For patients with WHO Grade 3 IDH-mutated CNS gliomas, radiation therapy must begin within 7 weeks after surgery . In individual cases, treatment may begin later, but no later than 10 weeks after surgery * 8\. At the time of study enrollment, the interval since the last surgery should be ≥ 2 weeks. Patients must have recovered from the effects of the surgery * 9\. The patient must consent and be able to undergo a neurocognitive baseline assessment prior to administration of the first radiation dose * 10\. The patient must provide written informed consent to participate in the study prior to enrollment * 11\. The study participant must be able to understand the purpose and implications of the study and must be willing to follow the clinical study instructions and, as far as can be anticipated, attend all scheduled study visits. * 12\. Women of childbearing potential must have a negative pregnancy test (serum or urine) that is no older than 7 days at the time of the first study intervention. * 13\. Laboratory values not older than 3 weeks prior to study enrollment: Absolute neutrophil count ≥ 1,500/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin (Hb) level \> 10 g/dL, Total bilirubin level ≤ 1.5 times the upper limit of normal, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 3 times the upper limit of normal, Creatinine level ≤ 1.5 times the upper limit of normal * Exclusion Criteria Patients who meet any of the following criteria will not be enrolled in the study. General exclusion criteria: * 1\. Concurrent participation in another clinical interventional study or participation in a clinical study that requires administration of an investigational drug within 30 days prior to study enrollment. * 2\. A physical or mental condition of the patient that, in the judgment of the study physician, could endanger the patient, could bias the study results, or could negatively affect the patient's participation in the clinical trial. * 3\. Known or ongoing abuse of drugs, alcohol, or medications. Indication-specific exclusion criteria: * 4\. At the time of tumor recurrence in patients with WHO Grade 2 IDH-mutated CNS gliomas, there is evidence on MRI of malignancy (e.g., marked contrast enhancement indicating Grade 3-4). * 5\. Previous radiation therapy to the head or head and neck region * 6\. Previous chemotherapy due to a CNS neoplasm * 7\. Severe comorbidities that limit compliance with study requirements * 8\. Malignant invasive tumor disease with a tumor-free period of \< 3 years * 9\. Evidence of leptomeningeal dissemination * 10\. Spinal or infratentorial tumor location * 11\. Patients with a known infection with the human immunodeficiency virus (HIV) * 12\. Patients with a newly diagnosed hepatitis infection or-at the discretion of the responsible study physician-a significant risk of reactivation
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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
2 sites. 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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Universitätsklinikum Essen
RECRUITINGEssen, Germany
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Universitätsklinikum Gießen und Marburg
RECRUITINGGiessen, Germany
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