Frameless Stereotactic Radiosurgery for Intact Brain Metastases

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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.

You cannot join if

• 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).

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Stereotactic Radiosurgery (Procedure): The SRS dose will depend on the maximum diameter of the gross tumor volume (GTV)

Randomized · Parallel · masking: None

Main goals

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

Other goals

• Progression free survival (PFS) rates estimated by the Kaplan-Meier method
• Overall survival rates
• Rates of radiation necrosis
• Rates of pseudoprogression
• Local failure rates
• Rate of acute central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities
• Rate of late central nervous system (CNS) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 2 and higher toxicities
• Rates of distant intracranial failure
• Rates of salvage therapy
• Association between dose and risk of radionecrosis or pseudoprogression

Planned enrollment: 166 (estimated).

• University of Chicago, Chicago, Illinois

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT02747303

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 13, 2026. Public record; not medical advice.