Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases

NCT03223922 | Recruiting DMC FDA Device

• 2 other identifiers: J1737IRB00128471
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This is a trial that evaluates the preservation of cognition and neuropsychiatric function following genu-sparing whole brain radiation in patients with brain metastases.

Conditions

Brain Metastases

Keywords

whole brain radiation therapy; genu of corpus callosum; cognitive function

Outcome Measures

Primary Outcomes (1)

• Rate of change of cognitive function

  Evaluate changes in cognition from baseline to 4 months following genu-sparing whole brain radiation therapy (GS-WBRT)

  4 months

Secondary Outcomes (5)

• Rate of change of white matter microstructure

  4, 6 and 12 months

• Rate of change of cognition

  4, 6 and 12 months

• Time to brain metastasis

  4, 6 and 12 months

• Rate of change in QoL

  4, 6 and 12 months

• Rate of change in other frontally-mediated functions

  4, 6 and 12 months

Study Arms (1)

Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy

EXPERIMENTAL

Genu-sparing whole brain radiation therapy (GS-WBRT) 30 Gy in 3 Gy per fraction

Radiation: whole brain radiation therapy

Interventions

whole brain radiation therapy RADIATION

Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy Genu-sparing whole brain radiation therapy (GS-WBRT) 30 Gy in 3 Gy per fraction

Also known as: WBRT

Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic proof or unequivocal cytologic proof solid tumor malignancy. This may be obtained from either the primary or any metastatic site
• Mini Mental State Examination (MMSE) ≥24
• Age≥ 18 years
• Karnofsky Performance Status (KPS) ≥70
• Patient does not have metastases to the genu
• Patient must be scheduled to undergo treatment with whole brain radiation therapy (WBRT) to manage the brain metastases
• Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
• Patient must have the ability to understand and the willingness to sign a written informed consent document
• All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
• Patient must have a minimal life expectancy of at least 6 months
• Patients receiving prior stereostatic radiosurgery (SRS) for brain metastases are eligible

You may not qualify if:

• Prior WBRT
• MMSE\<24
• Patient has brain metastases in the genu
• Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician prevent informed consent or completion of protocol treatment, and/or follow-up visits.
• KPS\<70
• Non-native English speakers will be excluded since patients often lose their faculty with the language they acquired second before their native language is affected in the context of cognitive decline. This could adversely affect performance on verbal cognitive tasks.
• Patients with absolute contraindication to MRI imaging are not eligible for the study

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

RECRUITING

The SKCCC at Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kristin Redmond, MD, MPH

  The SKCCC at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Redmond, MD

CONTACT

410-614-1642; kjanson3@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be treated to a total dose of 30 Gy with a once daily fractionation schedule of 3 Gy per fraction, administered five days per week.

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 21, 2017
• Study Start: July 19, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)