Phase 3 Study Comparing Stereotactic Radiosurgery to Hippocampal-Avoidant Whole Brain Radiotherapy Plus Memantine for Patients With 5 or More Brain Metastases

What this Trial Is About

Researchers are comparing two treatments for patients with 5 or more brain metastases stereotactic radiosurgery SRS and hippocampal-avoidant whole brain radiotherapy HA-WBRT combined with the drug memantine. This study aims to find out if SRS is better, the same, or worse than the usual treatment approach, which is whole brain radiation therapy alone. The study will assess how these treatments affect cancer control, overall survival, memory, quality of life, and cancer-related symptoms. Participants will be randomly assigned to receive either SRS, which delivers a high dose of radiation to specific small areas in the brain in a single session, or HA-WBRT plus memantine. HA-WBRT involves radiation to the whole brain while avoiding the hippocampus area to protect memory, given in 10 radiation fractions totaling 30Gy. Memantine is given starting at 5 mg and increased weekly to a target dose of 20 mg daily in divided doses. Treatment is provided as an outpatient procedure. During the study, participants will undergo regular assessments including MRI scans, neurocognitive testing, quality of life questionnaires, and blood tests to measure biomarkers. Researchers will monitor survival, brain cancer control, cognitive function, side effects, and treatment costs over 4.5 years. The study also includes collecting imaging and blood samples to understand treatment effects and brain changes. Participants are expected to be available for treatment, follow-up, and completing questionnaires throughout the study period.

Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases