A Pilot/Phase II Study of Gamma Knife Radiosurgery for Brain Metastases Using 3Tesla MRI and Rational Dose Selection

The aims of this study are to pilot a study to measure local control after "rational dose"
selected gamma knife radiosurgery for brain metastases and to measure treatment related
toxicity for rational dose selected gamma knife radiosurgery for brain metastases. In
addition, the quality of life and neurocognition of patients undergoing gamma knife
radiosurgery will be measured using the validated European Organisation for Research and
Treatment of Cancer QLQ-C30 and QLQ-BN20 survey instruments. "Rational dose selection" is a
concept wherein doses used for stereotactic radiosurgery is selected based on tumor volume,
prior irradiation with whole brain radiotherapy, and the relative radioresistance of the
tumor (radioresistant = melanoma, renal cell carcinoma, sarcoma; radiosensitive = breast
cancer, lung cancer, colorectal cancer, gastrointestinal cancers).

Eligible patients will have histologically confirmed cancer and MRI evidence of metastatic
disease within the brain. Patients will be eligible for the trial if intracranial
radiosurgery has been recommended for treatment of brain metastases. Patients will be
excluded if they have an extremely radiosensitive tumor (leukemia, lymphoma), a
radiosensitivity syndrome, a resection of a brain metastasis, or cannot tolerate the MRI or
placement of a stereotactic head frame. All patients must sign informed consent.

Radiation will consist of gamma knife radiosurgery delivered using doses selected based on
the concept of "rational dose selection" as summarized above.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed malignancy (not leukemia
or lymphoma). There must be metastatic brain disease apparent on magnetic resonance
imaging which offers a medical indication for brain radiation. - Age > 18

- Karnofsky Performance Status > 70

- MRI performed within 4 weeks of trial enrollment

- Medical oncologist or consenting physician verifies that chemotherapy options exist
after treatment with intracranial therapy, and that chemotherapy is planned to
initiate after completion of radiation. Or, survival as estimated by the medical
oncologist or enrolling physician is > 3 months.

Exclusion Criteria:

- Extremely radiosensitive tumor (lymphoma, leukemia)

- Radiosensitivity syndrome (scleroderma, dermatomyositis, other genetic syndrome that
predisposes to adverse radiotherapy complications)

- Evidence of leptomeningeal dissemination

- Resection of brain metastases, otherwise untreated with radiation for those brain
lesions (presenting for postoperative consolidative radiotherapy)

- Presence of a medical device (pacemaker, stent) or allergy that precludes contrast
enhanced MRI

- Patient is unable to tolerate placement of a stereotactic headframe

- Pregnancy