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New trial tests best way to zap large brain tumors before surgery

NCT ID NCT07329634

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This Phase 3 trial will compare two radiation approaches for people with large brain metastases (tumors that spread from other cancers). One group gets a single high-dose radiation before surgery; the other gets five smaller doses of radiation alone. The goal is to see which method better prevents tumor regrowth, radiation-induced brain damage, or spread of cancer in the brain lining. About 98 adults with tumors 2.5 to 6 cm will take part across multiple Polish centers.

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 (pre-surgery or multi-fraction radiation)
What this could lead to
If successful, this could establish a better radiation approach for large brain metastases, reducing the chance of tumor regrowth or brain complications.
What could go wrong
This is a relatively small Phase 3 trial (98 participants) and results may not apply to all patients. Both radiation types carry risks like brain swelling or tissue damage.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 98 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Sep 2032

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: * Age ≥18 years. * At least one brain metastasis appropriate for resection and not previously treated with SRS. * Lesions ≥2.5 cm and ≤6 cm in largest dimension. * Index lesion(s) will be treated, as outlined in the treatment section of the protocol. * Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate Neo-SRS, i.e., the ability to lie flat in a stereotactic head mask. * Any non-index lesion or lesions for which there is no possible resection must measure ≤4.0 cm in maximal dimension on the contrast MRI or CT brain scan obtained ≤35 days prior to pre-registration. Unresected lesions will be treated with SRS or mfSRS. * KPS \>60 * MRI confirms 1-10 lesions, one of which one is the index lesion. Each non-index lesion (up to nine) must measure ≤4 cm in maximal extent on contrast MRI and not otherwise require resection. * Known active or history of invasive primary non-central nervous system (CNS) cancer based on a documented histopathological diagnosis within the past three years. * Patient can tolerate surgery and SRS. * History/physical examination within 14 days prior to registration. * A negative urine or serum pregnancy test (in persons of childbearing potential, defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal for at least 12 consecutive months) within ≤14 days prior to registration. * Participants who are sexually active must agree to use medically acceptable forms of contraception during treatment during this study to prevent pregnancy. * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry. Exclusion Criteria: * No resectable lesion ≥2.5 cm. * Unresectable \>4 cm lesion. * Previous whole brain irradiation. * Progressive brain lesion treated with SRS. * Previous resection of brain metastases. * Leptomeningeal disease. * Lesion diameter \>6.0 cm, or more than 20 lesions in the brain. * Required emergency decompressive surgery for life-threatening intracranial hypertension (with a preference towards adjuvant SRS/mfSRS protocols). * Prior diagnosis of malignant brain tumor. * Pediatric patients (age \<18 years), pregnant women, and patients who are unable to give informed consent will be excluded.

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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

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  1. The official record

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    Open the record ↗

  2. A doctor treating you

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