Frameless Stereotactic Radiosurgery for Intact Brain Metastases

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).