Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Brain Metastasis
  • Cancer
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Background: Metastatic brain tumors occur more frequently than primary brain tumors and occur in approximately 25 percent of patients who die of cancer each year. The Radiation Therapy Oncology Group (RTOG) developed three prognostic classes using a recursive partitioning analysis (RPA) of a large d...

Background: Metastatic brain tumors occur more frequently than primary brain tumors and occur in approximately 25 percent of patients who die of cancer each year. The Radiation Therapy Oncology Group (RTOG) developed three prognostic classes using a recursive partitioning analysis (RPA) of a large database. Theses classes are based on Karnofsky Performance Status (KPS), age and disease status. The RTOG RPA classes do not include neuropsychological function as a measure of outcome. There is no consensus of standardization of test selection to measure changes in neuropsychological functioning in this patient population. Neuropsychological function has an important effect on quality of life and should be included when determining prognosis and treatment options for patients. Neuropsychological functioning is important when determining the effects of treatments and for measuring outcomes in clinical trials. Objectives: To identify the neuropsychological test scores which detect significant change in neuropsychological functioning in patients receiving radiation therapy for brain metastases. To examine the relationship between neuropsychological function and survival in patients receiving radiation therapy for brain metastases. Eligibility: Patients age 18 years and older. Pathologically confirmed primary malignancy with at least one intraparenchymal brain metastasis as identified on brain MRI scan with intravenous contrast. The patient must communicate in English in order to complete the neuropsychological evaluations. Design: This is a longitudinal study that will administer serial neuropsychological assessments to patients with brain metastases who receive radiation therapy. Patients will undergo a battery of neuropsychological tests prior to radiotherapy (WBRT or WBRT followed by SRS), and then after radiation at one month post-baseline (approximately 2 weeks after completion of radiation therapy), then at 3, and 6 months, and then every 3 months for up to 12 months after baseline. The test battery will involve approximately 40 minutes of direct cognitive testing and 15 minutes of questionnaires. There will be three cohorts of 20 patients each for a total of 60 patients. The three cohorts will be made up of differing histologies and will be sorted on the basis of their RTOG RPA Class.

Tracking Information

NCT #
NCT01445483
Collaborators
Not Provided
Investigators
Principal Investigator: DeeDee K Smart, M.D. National Cancer Institute (NCI)