Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors

Phase 3 Completed 554 enrolled Radiation Therapy Oncology Group NRG Oncology · collab National Cancer Institute (NCI) · collab

RandomizedParallel-groupDouble-blindSupportive care

Summary

RATIONALE: Memantine may be able to decrease side effects caused by whole-brain radiation therapy. It is not yet known if memantine is effective in preventing side effects caused by whole-brain radiation therapy. PURPOSE: This randomized phase III trial is studying memantine to see how well it works compared to a placebo in preventing side effects caused by whole-brain radiation therapy in patients with brain metastases from solid tumors.

Timeline

Start: 2008-03
Primary completion: 2011-04
Completion: 2016-12

Outcome

Missed primary endpoint

paper There was less decline in delayed recall in the memantine arm at 24 weeks (P = .059), but the difference was not statistically significant PMID 23956241 ↗

Publications

Brown PD, Pugh S, Laack NN, Wefel JS, Khuntia D, Meyers C, Choucair A, Fox S, Suh JH, Roberge D, Kavadi V, Bentzen SM, Mehta MP, Watkins-Bruner D; Radiation Therapy Oncology Group (RTOG). Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: a randomized, double-blind, placebo-controlled trial. Neuro Oncol. 2013 Oct;15(10):1429-37. doi: 10.1093/neuonc/not114. Epub 2013 Aug 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Memantine	Unknown	10 mg	Oral