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A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases

Primary Objective: Determine whether the addition of HA-WBRT increases time to neurocognitive failure at months 2, 4, 6 and 12 as measured by neurocognitive decline on a battery of tests: the Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall, Delayed Recall, and Delayed Recognition, Controlled Oral Word Association (COWA), and the Trail Making Test (TMT) Parts A and B. Secondary Objectives: Determine whether the addition of HA-WBRT preserves neurocognitive function at months 2, 4, 6 and 12 as separately measured by each test, the HVLT-R for Total Recall, Delayed Recall, and Delayed Recognition; COWA; and TMT Parts A and B. Evaluate the potential benefit of HA-WBRT in symptom burden, as measured by the M. D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Assessment of quality adjusted survival and health outcomes using the EQ-5D-5L. Compare cumulative incidence of progression and overall survival after WBRT versus HA-WBRT. Compare adverse events between the treatment arms according to the CTCAE v4.0 criteria. Exploratory Objectives: Collect serum, whole blood, and imaging studies for future translational research analyses. Evaluate MR imaging biomarkers of white matter injury and hippocampal volumetry at baseline and 6 months as potential predictors of neurocognitive decline and differential benefit from HA-WBRT as compared to WBRT. Association of symptom burden and anxiety/depression with neurocognitive function Evaluate the potential correlation between the prognostic scoring systems RTOG RPA and the diagnosis-specific graded prognostic assessment (DS-GPA) and neurocognitive function at baseline and overtime.

Primary Objective: Determine whether the addition of HA-WBRT increases time to neurocognitive failure at months 2, 4, 6 and 12 as measured by neurocognitive decline on a battery of tests: the Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall, Delayed Recall, and Delayed Recognition, Controlled Oral Word Association (COWA), and the Trail Making Test (TMT) Parts A and B. Secondary Objectives: Determine whether the addition of HA-WBRT preserves neurocognitive function at months 2, 4, 6 and 12 as separately measured by each test, the HVLT-R for Total Recall, Delayed Recall, and Delayed Recognition; COWA; and TMT Parts A and B. Evaluate the potential benefit of HA-WBRT in symptom burden, as measured by the M. D. Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) Assessment of quality adjusted survival and health outcomes using the EQ-5D-5L. Compare cumulative incidence of progression and overall survival after WBRT versus HA-WBRT. Compare adverse events between the treatment arms according to the CTCAE v4.0 criteria. Exploratory Objectives: Collect serum, whole blood, and imaging studies for future translational research analyses. Evaluate MR imaging biomarkers of white matter injury and hippocampal volumetry at baseline and 6 months as potential predictors of neurocognitive decline and differential benefit from HA-WBRT as compared to WBRT. Association of symptom burden and anxiety/depression with neurocognitive function Evaluate the potential correlation between the prognostic scoring systems RTOG RPA and the diagnosis-specific graded prognostic assessment (DS-GPA) and neurocognitive function at baseline and overtime.