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RECRUITINGINTERVENTIONAL

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

Preservation of Cognition and Neuropsychiatric Functioning With Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases: A Pilot Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form document - All patients must be informed of the investigational nature of this study and must be given written willing to sign a consent form in accordance with institutional and federal guidelines - Patient must have a minimal expected to live at least 6 months - Patients receiving prior stereostatic radiosurgery (SRS) for brain metastases are eligible Who Should NOT Join This Trial: - 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 willing to sign a consent form 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments Being Tested

RADIATION

whole brain radiation therapy

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

Locations (2)

Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
The SKCCC at Johns Hopkins
Baltimore, Maryland, United States