NRG-CC001

Terminated

Return to Protocol Table

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

Principal Investigator

Paul D. Brown

Status

Terminated

Open to Accrual

July 13, 2015

Closed to Accrual

March 12, 2018

Closed to Accrual & Treatment

July 31, 2018

Terminated

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

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Open Registration Checklist
Blank CRFs
Forms
Investigator Resources
Regulatory Resources
Study Memos
Other

The following NRG-CC001 form and form instructions are to be printed out and the form completed by the patient on paper. Once complete,the form must be entered electronically in Medidata Rave.

Patient History Form Instructions

NRG-CC001 A5 Standard Patient History Form

Pill Diaries

Pill Diary- Extended Release

Pill Diary- Twice Daily

Certification Worksheet


NRG-CC001 Neurocognitive Letter

NRG-CC001 Certification Worksheet

QOL Forms

NRG-CC001-MDASI–Brain Tumor_2(English)

NRG-CC001-MDASI–BT(French)

NRG-CC001USA (English) EQ-5D-5L

NRG-CC001 Canadian (English) EQ-5D-5L

NRG-CC001 Canadian (French) EQ-5D-5L

Specimen Transmittal Form

NRG-CC001 ST Form

 Neurocognitive Assessment Packets

NRG-CC001 Neurocognitive Assessment Packets 1-5(English)

NRG-CC001 Neurocognitive Assessment Packets 1-5 (French)

Imaging

NRG-CC001 Rave SOC Form

Canadian Resources

No Objection Letter, amendment 2-3

Clinical Trial Site Information Form, amendment 2-3

Research Ethics Board Approval Form

Qualified Investigator Undertaking Form

Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.