Phase 3 Study Comparing Targeted Stereotactic Radiosurgery to Whole Brain Radiation Avoiding the Memory Area Plus Memantine for Brain Metastases From Small Cell Lung Cancer

What this Trial Is About

Researchers are investigating treatments for small cell lung cancer that has spread to the brain, focusing on whether stereotactic radiosurgery SRS is better at preserving memory and thinking abilities compared to whole brain radiation therapy that avoids the hippocampus HA-WBRT combined with the drug memantine. This phase III trial evaluates cognitive function, symptom burden, survival outcomes, and side effects in patients receiving these treatments. The study also explores brain imaging biomarkers and the economic impact of therapies. Participants are randomly assigned to one of two groups. One group receives stereotactic radiosurgery, which delivers a high dose of radiation directly to brain tumors over one or several days. The other group receives hippocampal-avoidant whole brain radiation daily for two weeks along with memantine taken orally once or twice daily for up to 24 weeks. Both groups undergo blood sample collection and magnetic resonance imaging MRI throughout the study period. During the study, participants complete neurocognitive tests measuring memory and thinking skills, as well as patient-reported questionnaires about cognitive difficulties and symptoms. After treatment, follow-up visits occur every 2 to 3 months for one year and then every six months thereafter to monitor disease progression, survival, adverse events, and other outcomes. The main measurement focuses on the time until neurocognitive failure, assessed up to one year after treatment.

Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability