New trial tests best way to zap large brain tumors before surgery
NCT ID NCT07329634
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 98 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2032
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: * 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
Only the study team decides who joins. These are the ways to reach them.
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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.
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