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NRG-CC001

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/Co-Principal Investigator

Paul Brown, MD/ Vinai Gondi, MD

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 patients

Status

Activated July 13, 2015

Protocol Documents

  • The protocol and related documents are available at NRG-CC001 (Enter CTEP IAM credentials to access NRG Oncology Member Login)
  • Video recording of NCI-sponsored Webinar on NRG Hippocampal Avoidance Trials (CC001 & CC003) is available here.
  • Slide set from the NCI-sponsored Webinar on NRG Hippocampal Avoicance Trials (CC001 & CC003) is available here.
Copyright 2017 by NRG Oncology