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New radiation strategy before brain surgery shows promise

NCT ID NCT04503772

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested giving a precise, high-dose radiation treatment (stereotactic radiosurgery) to brain metastases before surgical removal. The goal was to see if this approach improves local control at 6 months. The trial enrolled 70 adults with up to 4 brain metastases from certain cancers. Participants received radiation followed by surgery within 3 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
stereotactic radiosurgery (SRS)
What this could lead to
If successful, this approach could reduce the chance of brain metastases returning after surgery.
What could go wrong
This is a small, non-randomized phase 2 study, so results may not be definitive. Risks include radiation side effects and the possibility that the treatment does not improve outcomes.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

70 people

The number who actually took part.

Started

Feb 2021

Finished

Nov 2025

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: * ≤ 4 distinct brain metastases, one with surgical indication * Diagnosis of primary histologically proven breast, digestive or non-small cells lung cancer * ≤ 5 cm larger diameter * Karnofsky performance status ≥ 70 * No contraindication for MRI * Possibility for the patient to be treat with both surgery and stereotactic radiotherapy * ≥ 18 years old * Estimated overall survival ≥ 6 months according to diagnosis specific - graded prognostic assessment (DS GPA) * Written inform consent signed * Affiliation to the French social security system * For women of childbearing age including those on luteinizing hormone-releasing hormone (LH-RH) agonists for ovarian suppression: inclusion negative serum pregnancy test (≤ 7 days prior to the start of preoperative stereotactic radiosurgery (SRS). Exclusion Criteria: * Lymphoma, leukaemia, multiple myeloma, germinal tumours or cerebral primary cancer * Metastases from small-cells lung cancer, kidney cancer, melanoma or sarcoma * Mass effect with deflection ≥ 5 mm from median line or hydrocephaly or compression 4th ventricle, patient neurologically unstable, need for emergency decompressive surgery * \> 4 brain metastases * Contraindication to anaesthesia, MRI or gadolinium injection * Proximity of the tumour with organs at risk which do not allow the prescribed dose to be reached in the envelope * Pregnant or breastfeeding woman * Anti vascular endothelial growth factor (VEGF) within 6 weeks before treatment * Documented leptomeningeal injury * History of irradiation of the encephalon in toto * History of stereotactic radiotherapy on metastasis to be operated on * Non-candidate patient for surgery * Surgical delay \> 3 days compared to stereotactic radiotherapy * Estimated survival \< 6 months by DS GPA * Patient under guardianship or curators * Psychological disorder (cognitive disorders, mental alertness, etc.) or social (deprivation of liberty by judicial or administrative decision) or geographical reasons that may compromise medical monitoring of the trial or compliance with treatment * Woman of childbearing age without effective contraception * Patient participating in another intervention study within 4 weeks prior to inclusion

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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.

Contacts and locations

Locations

  • CHU Grenoble Alpes

    Grenoble, 38700, France

  • Centre Hospitalier d'Annecy-Genevois

    Metz-Tessy, 74370, France

  • Centre Jean PERRIN

    Clermont-Ferrand, Puy-de-Dôme, 63800, France

  • Centre Léon BÉRARD

    Lyon, 69373, France

  • Hospices Civils de Lyon

    Lyon, 69002, France

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, France

  • Institut de cancérologie Strasbourg Europe (ICANS)

    Strasbourg, 67000, France

  • Institut de cancérologie de la Loire Lucien Neuwirth

    Saint-Priest-en-Jarez, 42270, France

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