A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases
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 (2 weeks
after 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.
Observational
Time Perspective: Prospective
To identify the neuropsychological test scores which detect significant change in neuropsychological functioning in patients receiving radiation therapy for brain metastases.
Kevin A Camphausen, M.D.
Principal Investigator
National Cancer Institute (NCI)
United States: Federal Government
080214
NCT01445483
September 2008
Name | Location |
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National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |