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Pre- or Post-Surgery Stereotactic Radiosurgery for Brain Metastases

This study is looking at the best timing for a specialized radiation treatment called stereotactic radiosurgery (SRS) when you have brain tumors that have spread from another part of your body (metastatic brain tumors) and can be removed by surgery. Researchers want to see if having SRS before surgery works better than having SRS after surgery. SRS delivers a high dose of radiation directly to the tumor, which may help protect healthy brain tissue. The study will compare how long it takes for new problems to appear, like the tumor growing back or side effects from radiation, and also look at overall survival and your quality of life. You may be able to join if you are 18 or older and have a brain tumor that can be surgically removed. The study aims to enroll 140 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 140 participants. It compares two approaches: stereotactic radiosurgery before surgery versus surgery before stereotactic radiosurgery.
What's involved
You would undergo either conventional surgery or stereotactic radiosurgery, along with CT scans, MRI scans, and questionnaires. The primary endpoint is measured up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to track the occurrence of certain events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03750227

Pre-Operative or Post-Operative Stereotactic Radiosurgery in Treating Patients With Operative Metastatic Brain Tumors

Recruiting
PHASE3Ages 18+InterventionalTreatment
Mayo Clinic
~140 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Conventional SurgeryQuestionnaire AdministrationStereotactic RadiosurgeryComputed TomographyMagnetic Resonance ImagingBiospecimen Collection

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Central nervous system (CNS) composite endpoint event (CNS-CE event)
Measured over Time from study randomization to documentation of the first CNS-CE event, assessed up to 5 years

Conditions

Malignant Solid Neoplasm
Metastatic Malignant Neoplasm in the Brain

Explore related trials

Metastatic Malignant Neoplasm in the BrainSolid Neoplasm

Where it's being run

4 sites across 4 states
Arizona1
Florida1
Maryland1
Minnesota1

Study leadership

  • Elizabeth Yan, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age \>= 18 years
Histological or cytological confirmation of solid tumor malignancy and/or clinical history of known or suspected metastatic disease with an intraparenchymal brain tumor consistent with brain metastasis based on clinical and radiologic findings
Clinical indication for surgical resection of one brain metastasis based on neurosurgery recommendation and patient deemed a surgical candidate
Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (=\< 10 metastases)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
Provide written informed consent or have a legally authorized representative who is responsible for the care and well-being of the potential study participant, provide consent
Willing to continue follow-up visits, either at the enrolling institution or with a local medical doctor as clinically appropriate, and according to the study timeline. Clinical notes and digital copies of imaging must be provided to the enrolling site if follow-up is done externally

Exclusion

Any of the following:
Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy. \* NOTE: Patients known to be HIV, but without clinical evidence of an immunocompromised state, are eligible for this trial
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Prior open neurosurgery for malignancy
Known or clinically suspected primary germ cell tumor, small cell carcinoma, or lymphoma
History of whole brain radiation therapy (WBRT)
Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants including MRI compatible pacemakers are eligible
Leptomeningeal metastasis/disease
A brain metastasis that is located =\< 5 mm of the optic chiasm
Any brain metastasis \> 5 cm in size
\> 10 brain metastases
Indication for surgical resection of \>= 2 brain metastases
Indication for long-term (anticipated greater than 4 weeks) 4 mg dexamethasone equivalent of steroids or bevacizumab
Actively enrolled on another brain metastases trial that is assessing the efficacy of either radiation or surgical interventions

What this trial measures

  • Central nervous system (CNS) composite endpoint event (CNS-CE event)Time from study randomization to documentation of the first CNS-CE event, assessed up to 5 years

    The CNS-CE event distributions will be estimated using the Kaplan-Meier method.