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Frameless Stereotactic Radiosurgery for Brain Metastases

This study is testing a type of radiation therapy called Stereotactic Radiosurgery (SRS) for people with brain metastases (cancer that has spread to the brain). Researchers want to see if not treating the edges of the tumor during radiation affects how long people live without their cancer growing. You might be able to join if you are an adult (18 or older) with a good general health status and a life expectancy of at least 3 months. You also need to have 1-5 brain tumors that are clearly defined and measure 3.0 cm or less. The study will measure how long you live without your cancer growing at 6 months after treatment. The current recruitment status is unclear.

Study design
This is a randomized study, meaning participants are assigned to different treatment groups by chance. The study plans to enroll 166 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival (how long you live without your cancer growing) will be measured at 6 months.

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

NCT02747303

Frameless Stereotactic Radiosurgery for Intact Brain Metastases

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Chicago
~166 participants
Updated 2025-12-29 on ClinicalTrials.gov
What's tested:Stereotactic Radiosurgery

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months
Measured over 6 months

Conditions

Brain Metastases

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Metastatic Malignant Neoplasm in the Brain

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Steven J. Chmura, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Robyn Hseu
[email protected]
773-834-3198
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult patients (≥ 18 years old) with an ECOG Performance Status 0-2 and a life expectancy of 3 months or more.
Histologically confirmed systemic malignancy with gadolinium contrast-enhanced MRI scan demonstrating 1-5 intraparenchymal brain metastases.
Well-circumscribed, measureable intraparenchymal brain lesion(s) with maximum tumor diameter ≤3.0 cm. If multiple lesions are present, the other(s) must not exceed 3.0 cm in maximum diameter. At least one lesion must be ≥1.0 cm in maximum diameter and ≥0.5 cm in a perpendicular diameter to be considered measurable disease.
Negative urine or serum pregnancy test done ≤ 14 days prior to CT simulation, for women of child-bearing potential only.
Ability to understand and willingness to sign a written informed consent document.

Exclusion

Diagnosis of germ cell tumor, small cell carcinoma or hematologic malignancy.
Metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts).
Diagnosis of leptomeningeal disease.
Prior cranial radiotherapy within 90 days of trial enrollment or prior SRS at any time to any lesion to be treated on protocol
Chemotherapy (including oral agents and targeted agents) or immunotherapy given within 14 days of SRS. Hormonal therapy is permitted. For Her2+ breast cancer patients, anti-Her2 therapy cannot be given within 14 days of SRS. Patients who are scheduled to receive trastuzumab emtansine after SRS cannot be enrolled.
Contraindications to gadolinium contrast-enhanced MRI (eg, non-compatible pacemaker, eGFR\<30, gadolinium allergy).

What this trial measures

  • Progression free survival (PFS) rates estimated by the Kaplan-Meier method at 6 months6 months

    Progression free survival (PFS) rates will be estimated by the Kaplan-Meier method and the 0-mm and 2-mm groups will be compared via the log-rank statistic with a one-sided test of significance, using follow-up data up to 6 months.