Neuropsychological Measures in Patients Undergoing Radiation Therapy for Brain Metastases



Status:Archived
Conditions:Cancer, Cancer, Cognitive Studies, Psychiatric
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2008

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A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases


RATIONALE: Learning about the neuropsychological function in patients undergoing radiation
therapy for brain metastases may help doctors learn more about the long-term effects of
radiation therapy and help plan the best treatment.

PURPOSE: This clinical trial is studying neuropsychological measures in patients undergoing
radiation therapy for brain metastases.


OBJECTIVES:

Primary

- To identify neuropsychological test scores that detect significant change in
neuropsychological functioning in patients undergoing radiotherapy for brain
metastases.

- To examine the relationship between neuropsychological function and survival of these
patients.

Secondary

- To further examine whether other measures from the following battery of tests detect
significant change in neuropsychological function or predict prognosis in these
patients: North American Adult Reading Test-Short Form (NART-35), Hopkins Verbal
Learning Test (HVLT), WAIS-III Digit Span Subtest, WAIS-III Symbol Search Subtest, Ruff
2 and 7 Selective Attention Test, Trail Making Test Part A and B (TMT), Controlled Oral
Word Association Test (COWAT), Grooved Pegboard, Barthel Index, and the Functional
Assessment of Cancer Therapy-Brain (FACT-Br).

- To examine the relationship between the RTOG recursive partitioning analysis (RPA)
classification for brain metastasis survival and baseline neuropsychological
functioning in these patients.

- To examine the strengths and weaknesses in neuropsychological functioning of these
patients after radiotherapy.

- To explore the neuropsychological functioning of patients treated with different
therapies (e.g., chemotherapy, corticosteroids, or complete surgical resection).

- To investigate the relationship between neuropsychological functioning, brain lesions
(e.g., number and volume), MRI abnormalities, biomarkers, and disease progression or
recurrence in these patients.

- To investigate the role of biomarkers, including NSE, S100B, MMPs, and VEGF, as
potential markers of brain injury and disease progression using serum, plasma, and
urine samples from these patients.

- To gather baseline neuropsychological data for use as a reference in the development of
new clinical trials involving this patient population in the Radiation Oncology Branch
(ROB).

OUTLINE: Patients are stratified according to RTOG recursive partitioning analysis (RPA)
classification.

Patients undergo whole brain radiotherapy once daily 5 days a week for 2 weeks (10
fractions). Some patients may then undergo stereotactic radiosurgery boost.

Patients undergo neuropsychological testing (involving 40 minutes of direct cognitive
testing and 15 minutes of questionnaires) at baseline and at 1, 3, 6, 9, and 12 months.

Blood and urine samples are collected periodically for laboratory biomarker studies. Blood
samples are analyzed for NSE and S100B by ELISA. Urine samples are analyzed for MMP by
ELISA.


We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
1-800-422-6237
National Cancer Institute (NCI) The National Cancer Institute (NCI) is part of the National Institutes...
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Bethesda, MD
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