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Pre-operative vs. Post-operative Stereotactic Radiosurgery for Brain Metastases

This study is looking at two different ways to treat cancer that has spread to the brain (brain metastases) using stereotactic radiosurgery (SRS). SRS is a type of radiation treatment that delivers a high dose of radiation directly to the tumor. Researchers want to see if giving SRS before surgery works better than giving it after surgery. They will compare how well each approach prevents new tumor growth in the brain and affects your quality of life. About 180 people are expected to join this study. The study is currently evaluating its status. You may be able to join if you are 18 or older, have brain metastases, and are a candidate for SRS within 30 days of surgery.

Study design
This is an interventional study where participants are randomly assigned to one of two groups. It plans to enroll 180 participants.
What's involved
Participants will undergo stereotactic radiosurgery (SRS) either before or after surgery. They will also complete quality-of-life assessments and questionnaires.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, leptomeningeal disease (LMD)-free rate, will be measured at 1 year.

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NCT03741673

Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~180 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Quality-of-Life AssessmentQuestionnaire AdministrationStereotactic Radiosurgery

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Leptomeningeal disease (LMD)-free rate
Measured over At 1 year

Conditions

Malignant Neoplasm
Metastatic Malignant Neoplasm in the Brain

Explore related trials

Malignant NeoplasmMetastatic Malignant Neoplasm in the Brain

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Debra N Yeboa · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

The primary lesion pre-operatively can have a maximum diameter of =\< 4 cm for single fraction and =\< 7 cm for multifraction therapy
Patients must be considered candidates for SRS within +/- 30 days of surgical resection as defined by either history and physical (H\&P) or presentation at brain metastasis tumor board conference note
Patients must have a Karnofsky performance scores \>= 70 or Eastern Cooperative Oncology Group (ECOG) \>= 2 within 30 days of enrollment
Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form
No radiographic evidence of leptomeningeal disease on MD Anderson Cancer Center (MDACC) departmental radiology report or study neuro-radiologist review
Documented history of malignancy

Exclusion

Patients who have received prior radiation therapy to the brain for any reason
The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma
For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy)

What this trial measures

  • Leptomeningeal disease (LMD)-free rateAt 1 year

    Aalen-Johansen estimates will be used for LMD. Uni- and multi-variable analysis of time to LMD will be done using Fine-Gray proportional hazards regression. Model assumptions will be verified graphically by residual analyses.