RECRUITING Phase 2 ClinicalTrials.gov

Memory Avoidance Whole Brain Radiotherapy vs Hippocampal Avoidance Whole Brain Radiotherapy (Athena 2 Trial)

Sponsor: Case Comprehensive Cancer Center • ClinicalTrials.gov ID: NCT07248228

Registry updated: 2026-09-22

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Description

Participants in this research study have cancer that has spread to their brain, called brain metastases. One treatment for this type of cancer is called whole brain radiotherapy that stays away from a specific neurocognitive substructure, called the hippocampus, combined with medication to preserve cognitive function. This study compares that approach to another approach of whole brain radiotherapy that stays away from additional structures that are thought to have a role in cognitive function. Researchers want to see if there is a difference in the preservation of cognitive function between these two approaches.

Interventions

MA-WBRT (Memory Avoidance Whole Brain Radiation Therapy (MA-WBRT)) (Radiation)
Participants will receive 10 daily fractions of WBRT per standard of care. Participants receiving MA-WBRT will receive WBRT that avoids the hippocampus, the amygdala, corpus callosum, fornix, hypothalamus, and pituitary.
HA-WBRT (Hippocampal Avoidance Whole Brain Radiation Therapy (HA-WBRT)) (Radiation)
Participants will receive 10 daily fractions of WBRT per standard of care. Participants receiving HA-WBRT will receive WBRT that avoids the hippocampus.
Memantine (Drug)
Memantine is prescribed per standard of care. Participants will continue on memantine for 24 weeks. The target dose for memantine is 20 mg (10 mg divided twice daily). Dose is escalated by 5 mg per week to target of 10 mg twice daily (i.e., 5 mg a day for week 1, then 5 mg twice daily for week 2, then 10 mg in the morning and 5 mg in the evening for week 3, then 10 mg in the morning and 10 mg in the evening by week 4). Participants will also be prescribed extended release memantine. The target dose for extended release memantine is 28 mg. Dose is escalated by 7 mg per week to target of 28 mg daily (i.e., 7 mg a day for week 1, then 14 mg a day for week 2, then 21 mg a day for week 3, then 28 mg a day for by week 4).

Eligibility criteria

Inclusion Criteria: * Participants must have histologically, cytologically, or radiographically confirmed diagnosis of solid tumor with brain metastases * Age \>18 years * Performance status: Karnofsky Performance Status (KPS) ≥ 70 * Estimated life expectancy of at least 3 months * Participant must be considered a candidate for WBRT by the treating physician * Participant must be a primary English speaker and have the ability to understand and the willingness to sign an English written informed consent document * Participant has at least 10 brain metastases or is otherwise suitable for WBRT Exclusion Criteria: * Prior whole brain radiation * Participant has Multiple Sclerosis, Alzheimer's, dementia, or mental disability * Pregnant or breastfeeding women are excluded from this study. * Participant is not able to receive an MRI * Participant has metastasis within avoidance neurocognitive substructures (hippocampus, amygdala, fornix, corpus callosum, pituitary, amygdala)

Conditions

Brain Metastases

Locations

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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