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Type(s) of Cancer
CNS
Study Phase
Phase 3
Study Completion Date
2018-04-30
NCT02360215Uploaded 05-12-2021
Access via NCI by Request
PDS UID: nci-data-468
A Randomized Phase III Trial of Memantine and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Patients With Brain Metastases
Provider Information
Provider Data DescriptionThis dataset contains baseline, treatment, efficacy, and health-related quality of life data from trial NCT02360215 to reproduce the results in the primary publication (PubMed ID 32058845). Dataset NCT02360215-D2 contains toxicity data for this publication.
SponsorNRG Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in reducing neurocognitive decline in patients with cancer that has spread from the primary site (place where it started) to the brain. Whole brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately, the majority of patients with brain metastases experience cognitive (such as learning and memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function by binding to and inhibiting channels of receptors located in the central nervous system. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal region during WBRT, may reduce the radiation dose to the hippocampus and help limit the radiation-induced cognitive decline. It is not yet known whether giving memantine hydrochloride and WBRT with or without hippocampal avoidance works better in reducing neurocognitive decline in patients with brain metastases.
ConditionsCognitive Impairment
Metastatic Malignant Neoplasm in the Brain
Solid Neoplasm
Intervention TypeRadiation: Whole brain radiation therapy with hippocampal avoidance
Drug: Memantine
Radiation: Whole brain radiation therapy
Drug(s)Drug: Memantine
Total Enrolled518
RandomizationRandomized
Blinding MethodNone
Arms InterventionWBRT + Memantine - Experimental
HA-WBRT/IMRT+ Memantine - Experimental
Secondary IDNCI-2015-00030
PubMed (PMID)32058845
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT02360215-D1
Data DictionaryNCT02360215-D1-Data-Dictionary_1.pdf
DATANCT02360215-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT02360215-D2
Data DictionaryNCT02360215-D2-Data-Dictionary_1.pdf
DATANCT02360215-D2-Dataset_1.csv
OTHERREADME.pdf
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