An official website of the United States government
Genu-Sparing Whole-Brain Radiotherapy in Preserving Cognition and Neuropsychiatric Functioning in Patients with Solid Tumors with Brain Metastases
Trial Status: active
This trial studies the side effects and how well genu-sparing whole-brain radiotherapy works in preserving cognition and neuropsychiatric functioning in patients with solid tumors that have spread to the brain. Genu-sparing whole-brain radiotherapy delivers radiation therapy to the brain while decreasing radiation exposure to an area of the brain called the corpus callosum genu, and it may decrease side effects from radiation to the brain such as memory and thinking problems.
Inclusion Criteria
Histologic proof or unequivocal cytologic proof of solid tumor malignancy; this may be obtained from either the primary or any metastatic site
Mini-mental status exam (MMSE) >= 24 OR Montreal Cognitive Assessment Functional Test (MoCA) Blind >= 18.
Karnofsky performance status >= 70
Patient must be scheduled to undergo treatment with WBRT to manage the brain metastases
Patient does not have any brain metastases in the genu
Patients of childbearing potential (male or female) must practice adequate contraception
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 stereotactic radiosurgery (SRS) for brain metastases are eligible
Exclusion Criteria
Prior WBRT
MMSE < 24 or MoCA Blind < 18.
Patients with 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
Karnofsky performance status (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 magnetic resonance imaging (MRI) imaging are not eligible for the study
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03223922.
I. Evaluate changes in cognition from baseline to 4 months following genu-sparing whole brain radiation therapy (GS-WBRT).
SECONDARY OBJECTIVES:
I. Evaluate change in white matter microstructure following GS-WBRT utilizing diffusion tensor imaging (DTI).
II. Evaluate changes in cognition from baseline to 4, 6 and 12 months following GS-WBRT.
III. Document development of brain metastases in the spared genu of the corpus callosum.
IV. Document changes in quality of life (QOL), neuropsychiatric symptoms, and functioning in patients receiving GS-WBRT from pre-treatment to 4, 6 and 12 months following GS-WBRT.
V. Document the stability of other frontally-mediated cognitive functions in those receiving GS-WBRT from pre-treatment to 4, 6 and 12 months following GS-WBRT.
OUTLINE:
Patients undergo GS-WBRT once daily 5 days per week for a total of 10 fractions.
After completion of study treatment, patients are followed up for 24 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center