Assessment of Neurocognitive Function in Patients With Multiple Brain Metastases Undergoing Stereotactic Radiosurgery or Stereotactic Body Radiation Therapy

PRIMARY OBJECTIVES:

I. Assessment of neurocognitive function at months 4.

SECONDARY OBJECTIVES:

I. Assessment of neurocognitive function at months 2, 6, and 12 as measured by neurocognitive
decline on a battery of tests.

II. Assessment of symptom burden, as measured by the M.D. Anderson Symptom Inventory- Brain
Tumor Module (MDASI-BT).

III. Assessment of quality adjusted survival and health outcomes using the European Quality
of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L).

IV. Assessment of local control, in brain control. V. Assessment of progression free survival
(PFS), and overall survival (OS). VI. Assessment of side effects and toxicities.

Inclusion Criteria:

- Pathologically proven solid tumor malignancy (except for small cell lung cancer
[SCLC], germ cell tumor)

- Karnofsky performance status >= 60

- 1 to 10 brain mets (no more than two lesions and/or cavities >= 3 cm in maximum
diameter)

- Maximum diameter of brain metastasis or resection cavity is 6 cm

- Serum creatinine =< 3 mg/dL and creatinine clearance >= 30 ml/min

- Patients must have the psychological ability and general health that permits
completion of the study requirements and required follow up; patients must be willing
to complete neurocognitive assessments at pre-specified time points outlined in the
protocol

- Women of childbearing potential must have a negative beta-human chorionic gonadotropin
(HCG) pregnancy test documented within 21 days prior to registration

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
4 months after last dose

- Patient able to provide his/her own written informed consent and speak English

Exclusion Criteria:

- Patient with diagnosis of glioma, or other World Health Organization (WHO) grade II -
IV primary brain tumor

- Prior brain surgery =< 14 days prior to enrollment

- Planned chemotherapy during radiosurgery

- Leptomeningeal metastases

- Intractable seizures while on adequate anticonvulsant therapy—more than 1 seizure per
week for the past 2 months

- Pregnant women