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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT07248228
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Brain Metastases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Memory Avoidance Whole Brain Radiation Therapy (MA-WBRT)
  • Active Comparator: Hippocampal Avoidance Whole Brain Radiation Therapy (HA-WBRT)

Primary Outcome Measure

Time to neurocognitive failure (NCF) [ Time Frame: Up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106
Haley Perlow, MD
Haley Perlow, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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