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Frameless Stereotactic Radiosurgery for Intact Brain Metastases
RecruitingPhase 2
The Clinical Relevance of Margins in Frameless Stereotactic Radiosurgery for Intact Brain Metastases: a Randomized Trial of 0 vs 2 mm Margins
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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).
About the study
This is a randomized study to determine if not treating planning target volume (PTV) margins during radiation therapy worsens progression free survival rates in patients with brain metastases.
What is being tested
- Stereotactic Radiosurgery (procedure)
Sponsor: University of Chicago · Participants: 166 · Started: Sep 5, 2023
Contact the study team
- Robyn Hseu · Phone: 773-834-3198
Official record on ClinicalTrials.gov — NCT02747303
Locations in the U.S.
| Illinois | University of Chicago, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.