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NCT02360215 · ClinicalTrials.gov registry record · Phase 3
Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases
A Phase 3 study, sponsored by NRG Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 518
- Enrollment target
NCT02360215 is a Phase 3 study that has completed, run by NRG Oncology. The registered enrollment target is 518 participants.
The verdict
NCT02360215, a Phase 3 study, has completed, sponsored by NRG Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 518 participants
- Enrollment target
Study Summary
This 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.
Interventions
- DRUG Memantine
- RADIATION Whole brain radiation therapy with hippocampal avoidance
- RADIATION Whole brain radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2015-07 |
| Est. Completion | 2019-08-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02360215
The ClinicalTrials.gov registry entry for NCT02360215 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 518 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Memantine is the first listed.
NCT02360215 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02360215 about?
NCT02360215 is a clinical study titled "Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases". This 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) ...
What is the current status of trial NCT02360215?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 518 participants. The study started on 2015-07. Estimated completion is 2019-08-26.
What interventions are being tested in trial NCT02360215?
The interventions under investigation include: Memantine (DRUG), Whole brain radiation therapy with hippocampal avoidance (RADIATION), Whole brain radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT02360215?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
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