Recruiting
Phase 2

Whole Brain Radiotherapy

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07248228

Conditions

Brain Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MA-WBRT (Memory Avoidance Whole Brain Radiation Therapy (MA-WBRT))

HA-WBRT (Hippocampal Avoidance Whole Brain Radiation Therapy (HA-WBRT))

Memantine

Study Details

Brief summary:

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.

Conditions

Brain Metastases

Study ID

NCT07248228

Start date

Jul 9, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Memory Avoidance Whole Brain Radiation Therapy (MA-WBRT)

active comparator: Hippocampal Avoidance Whole Brain Radiation Therapy (HA-WBRT)

Interventions

MA-WBRT (Memory Avoidance Whole Brain Radiation Therapy (MA-WBRT))

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))

Participants will receive 10 daily fractions of WBRT per standard of care. Participants receiving HA-WBRT will receive WBRT that avoids the hippocampus.

Memantine

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).

Primary outcome measure

  • Time to neurocognitive failure (NCF) [ Time Frame: Up to 12 months ]
  • Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Day 1 (prior to WBRT treatment) ]
  • Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Month 3 ]
  • Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Month 6 ]
  • Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Month 9 ]
  • Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Month 12 ]
  • Controlled Oral Word Association Test (COWAT) [ Time Frame: Day 1 (prior to WBRT treatment) ]
  • Controlled Oral Word Association Test (COWAT) [ Time Frame: Month 3 ]
  • Controlled Oral Word Association Test (COWAT) [ Time Frame: Month 6 ]
  • Controlled Oral Word Association Test (COWAT) [ Time Frame: Month 9 ]
  • Controlled Oral Word Association Test (COWAT) [ Time Frame: Month 12 ]
  • Brief Visuospatial Memory Test-Revised (BVMT-R) [ Time Frame: Day 1 (prior to WBRT treatment) ]
  • Brief Visuospatial Memory Test-Revised (BVMT-R) [ Time Frame: Month 3 ]
  • Brief Visuospatial Memory Test-Revised (BVMT-R) [ Time Frame: Month 6 ]
  • Brief Visuospatial Memory Test-Revised (BVMT-R) [ Time Frame: Month 9 ]
  • Brief Visuospatial Memory Test-Revised (BVMT-R) [ Time Frame: Month 12 ]
  • Trail Making Test (TMT) [ Time Frame: Day 1 (prior to WBRT treatment) ]
  • Trail Making Test (TMT) [ Time Frame: Month 3 ]
  • Trail Making Test (TMT) [ Time Frame: Month 6 ]
  • Trail Making Test (TMT) [ Time Frame: Month 9 ]
  • Trail Making Test (TMT) [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Haley Perlow, MD

(216) 286-3906haley.perlow@uhhospitals.org

Locations

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Haley Perlow, MD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Whole brain radiotherapy
  • Memory-avoidance whole brain radiotherapy
  • Hippocampal-avoidance whole brain radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-06.