Brain radiation face-off: one big dose vs. several smaller ones
NCT ID NCT05102747
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two types of radiation for people with up to 5 brain metastases from solid tumors. One group gets a single high dose of radiation, the other gets three smaller doses over a week. The goal is to see which approach better controls tumors and causes fewer side effects like brain tissue damage. The trial plans to enroll 504 participants.
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
- What this could lead to
- If this trial succeeds, it could establish a new standard radiation schedule that reduces side effects like brain tissue damage while still controlling tumors.
- What could go wrong
- This is a phase 3 trial, but it compares two existing treatments, so no breakthrough is expected. The benefit of the new schedule may be small, and some patients may still experience side effects.
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 504 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Jan 2031
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: * Patients aged ≥ 18 years * WHO performance status 0 or 1; * Patient eligible for SRT after a multidisciplinary committee decision; Patient with BMs from radioresistant cancer (renal cell carcinoma, sarcoma, melanoma) is eligible * Patient having up to 5 BM of solid tumours with an histologically proven diagnoses; patients who have had a metastasectomy and having 1 to 4 BM lesions is eligible (ANOCEF recommendations); post-operative cavity must be treated by radiosurgery according to local procedures with respect of non-inclusion criteria\* (cavity will not be analyzed for efficacy) * Presence of at least one and no more than 5 target lesions for SRT, measuring between 10 and 25 mm. In the event of synchronous BM, lesions measuring less than 10mm or more than 25mm (1 to 4 lesions) will be treated at the discretion of the investigator * Max cumulative GTV of 30cm3 * Normal complete blood count (CBC) * Absence of bleeding BM or meningeal carcinomatosis; * Symptomatic BM are allowed * DS-GPA score: * Renal cancer: DS-GPA 2,5 or more * Breast cancer: DS-GPA 2,5 or more * Melanoma: DS-GPA 1.5 or more * Gastro-instestinal (GI) cancer: DSGPA 3 or more * Adenocarcinoma lung cancer: DS-GPA 2 or more (DS-GPAmol) * Squamous lung cancer : DS-GPA 2,5 or more (DS-GPAmol) * For cancers where the DS-GPA score is not applicable, the patient is eligible if eligibility criteria are met * Patient with no concomitant systemic treatment; in case of ongoing systemic treatment, wash out period of 3-7 days before and after SRT, depending of drug and at the discretion of investigator; * Patient sufficiently cooperating to perform the treatment with the use of a thermoformed mask; * Patient whose neuropsychological abilities allow to follow the requirements of the protocol; * Female with childbearing potential must use adequate contraception * Signed informed consent formOligoBM-01 Trial - ID-RCB number: 2021-A01622-39 - version 3.1 dated from 2023-06-22 Page 9 of 51 * Patients affiliated to the social security system Exclusion Criteria: * Patients with current or past history small cell lung cancer, germ-cell tumours, lymphoma, leukemia and multiple myeloma within the last 5 years; * Patients with metastases in the brain stem, or within 1 cm of the optic apparatus; * Patients with an associated neurodegenerative disease; * Any symptoms not attributable to BM or cancer disease requiring long term corticosteroid use (regardless of dose); * Contraindication to perform the brain MRI or gadolinium or iodinated contrast; * Known hypersensitivity to the contrast product or to any their excipients * Patients with previous brain stereotactic irradiation * Whole brain irradiation history; * Haemorrhagic metastasis; * Ongoing anti angiogenic treatment (treatment should be held 3-7 days before irradiation and re-initiated 3-7 days after irradiation for patient to be eligible); * Patients with too close brain lesions for whom a treatment plan on one target metastasis delivers a dose \> 5 Gy on other concomitant metastasis ; * Patient deprived of liberty or under guardianship; * Known pregnancy or breastfeeding * Any geographical conditions, social and associated psychopathology that may compromise the patient's ability to participate in the study; * Participation in a therapeutic trial for less than 30 days. * Patient deprived of freedom or under guardianship
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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
15 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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CHU
NOT_YET_RECRUITINGBordeaux, France
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CHU
RECRUITINGBrest, France
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CHU
NOT_YET_RECRUITINGGrenoble, France
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Centre Antoine Lacassagne
NOT_YET_RECRUITINGNice, France
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Centre Eugène Marquis
RECRUITINGRennes, France
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Centre François Baclesse
RECRUITINGCaen, 14076, France
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Centre Guillaume le Conquérant
RECRUITINGLe Havre, France
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Centre Henri Becquerel
NOT_YET_RECRUITINGRouen, France
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Centre d'Oncologie et Radiothérapie Saint-Jean
RECRUITINGSaint-Doulchard, France
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Centre hospitalier Lyon Sud
NOT_YET_RECRUITINGPierre-Bénite, France
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Groupe hospitalier Bretagne Sud
RECRUITINGLorient, France
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Gustave Roussy
NOT_YET_RECRUITINGVillejuif, France
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Institut Bergonié
NOT_YET_RECRUITINGBordeaux, France
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Institut Claudius Regaud
NOT_YET_RECRUITINGToulouse, France
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La Pitié Salpétrière
NOT_YET_RECRUITINGParis, France
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