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
Date Opened To Accrual
July 13 2015
Date Closed to Accrual
March 12 2018
Date of Study Termination
August 26 2019
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
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.