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Title:
Preservation of Cognition and Neuropsychiatric Functioning with Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases: A Pilot Study
Protocol Number:
J1737
Phase:
Pilot
Physician:
Kristin Redmond
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
Primary Objectives: Evaluate changes in cognition from baseline to 4 months following genu-sparing whole brain radiation therapy (GS-WBRT)Secondary Objectives: Evaluate changes in white matter microstructure following GS-WBRT utilizing diffusion tensor imaging (DTI). Evaluate changes in cognition from baseline to 4, 6, and 12 months following GS-WBRT. Document the development of brain metastases in the spared genu of the corpus callosum. Document changes in QOL, neuropsychiatric symptoms, and functioning in patients receiving GS-WBRT from pre-treatment to 4, 6, and 12 months following GS-WBRT. 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.
Eligibility:
Eligibility Criteria: Histologic proof or unequivocal cytologic proof of solid tumor malignancy that can be obtained from either the primary or metastatic site. Mini Mental State Examination score greater than or equal to 24. Age 18 or older. KPS score greater than or equal to 70. Must be scheduled to undergo treatment with Whole Brain Radiation Therapy to manage the brain metastases. Patients of childbearing potential (male or female) must be willing to practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child. Minimal life expectancy of at least 6 months. Patients receiving prior stereostatic radiosurgery for brain metastases are eligible. 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 informants will also need to sign a separate consent form.Exclusion CriteriaPrior Whole Brain Radiation Therapy. Mini Mental State Examination less than 24. KPS less than 70. Patients who 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. Patients with absolute contraindication to MRI imaging are not eligible for the study. 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.
Treatment:
Before the patient can begin the study, the following exams, tests, and procedures will need to be completed: demographic history, medical history, physical exam with vital signs, MMSE screen, Hopkins Adult Reading Test, performance status, neurocognitive testing, self-report questionnaires, toxicity assessment, and acute toxicity assessment. If applicable, the patient must have a negative pregnancy test. All patients will also require a CT simulation without contrast, and a brain MRI prior to study initiation. The 15 patients who are selected for the DTI will also need to complete the imaging as part of their baseline. This research scanner estimates location, orientation, and anisotropy of the white matter tracks of the brain, and will be used to quantitatively measure neuronal injury. Patient informants will also need to complete the baseline informant report questionnaires.All patients will undergo CT simulation and will be treated in a supine position using an aquaplast mask system for immobilization. Patients will be treated to a total dose of 30Gy with a once daily fractionation schedule of 3Gy per fraction, administered 5 days a week. Patients will be evaluated at least weekly during the radiation therapy. For radiation therapy interruptions that go beyond 14 days, the patient will be removed from the protocol treatment. Short term side effects of the radiation therapy include fatigue, alopecia, erythema or irritation of the skin, dry skin, headaches, worsening of current symptoms, edema of brain requiring steroids, ear pain or discomfort, damage to the baby if the patient is or becomes pregnant, seizures, neurologic deficits depending on tumor location, edema of the brain requiring surgery, or death. Long term toxicities include memory loss, cataracts, edema of the brain requiring steroids, vision loss, hearing loss, necrosis of brain requiring surgery, or second tumor or cancer caused by radiation. This study will follow patients for 24 months after the GS-WBRT or until the time of data analysis. At 4, 6, and 12 months following GS-WBRT patients will need to complete neurocognitive testing, QOL questionnaires, and be assessed for toxicities. Patients will also have standard of care MRIs at 2, 4, 6, 9, 12, 16, 20, and 24 months following GS-WBRT. The subset of 15 patients that will have scans performed on the 3-Tesla research scanner at the East Baltimore Campus will also need to have a DTI done at the 4 month follow-up. Patient informants will complete the same questionnaires they were given for the baseline assessment at 4, 6, and 12 months following GS-WBRT.
Population:
Adult
Last Update
03/05/2019 05:03 AM