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Brain radiation face-off: one big dose vs. several smaller ones

NCT ID NCT05102747

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 504 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU

    NOT_YET_RECRUITING

    Bordeaux, France

  • CHU

    RECRUITING

    Brest, France

  • CHU

    NOT_YET_RECRUITING

    Grenoble, France

  • Centre Antoine Lacassagne

    NOT_YET_RECRUITING

    Nice, France

  • Centre Eugène Marquis

    RECRUITING

    Rennes, France

  • Centre François Baclesse

    RECRUITING

    Caen, 14076, France

  • Centre Guillaume le Conquérant

    RECRUITING

    Le Havre, France

  • Centre Henri Becquerel

    NOT_YET_RECRUITING

    Rouen, France

  • Centre d'Oncologie et Radiothérapie Saint-Jean

    RECRUITING

    Saint-Doulchard, France

  • Centre hospitalier Lyon Sud

    NOT_YET_RECRUITING

    Pierre-Bénite, France

  • Groupe hospitalier Bretagne Sud

    RECRUITING

    Lorient, France

  • Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, France

  • Institut Bergonié

    NOT_YET_RECRUITING

    Bordeaux, France

  • Institut Claudius Regaud

    NOT_YET_RECRUITING

    Toulouse, France

  • La Pitié Salpétrière

    NOT_YET_RECRUITING

    Paris, France

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