NRG-CC001

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

Principal Investigator

Paul Brown, MD

Status

Terminated

Disease Site

Symptom Management [CC]

Other

Phase

III

Developmental Therapeutics

No

Primary Objective

To 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.

Patient Population

Pathologically (histologically or cytologically) proven diagnosis of solid tumor malignancy within 5 years prior to registration. Patients may have had prior therapy for brain metastasis, including radiosurgery and surgical resection. Patients must have completed prior therapy by at least 14 days prior to registration for surgical resection and 7 days for radiosurgery.

Target Accrual

510