View Clinical Trial (Medical Research Study)
A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Cognitive/Functional Effects - Metastatic Cancer - Psychosocial Effects of Cancer and Its Treatment - Unspecified Adult Solid Tumor, Protocol Specific |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed primary malignancy
- At least one intraparenchymal brain metastasis as identified on brain MRI with IV
contrast
- Meets one of the following criteria according to the RTOG recursive partitioning
analysis (RPA) classification:
- Class I
- Age 65 and under
- Controlled primary tumor
- No extracranial metastases
- Karnofsky performance status (KPS) 70-100%
- Class II
- KPS 70-100% AND meets at least 1 of the following criteria:
- Uncontrolled or synchronous primary disease
- Extracranial metastases
- Over 65 years of age
- Class III
- KPS less than 70%
- No leptomeningeal metastases
PATIENT CHARACTERISTICS:
- See Disease Characteristics
- Able to communicate in English
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No impaired cognition that would preclude giving informed consent
- No pre-existing or active psychiatric or neurologic impairment (not caused by the
brain metastasis), other medical condition, or clinically significant unrelated
systemic illness, that in the opinion of the investigator, would preclude study
participation
- No HIV positivity
PRIOR CONCURRENT THERAPY:
- No treatment for prior brain metastasis
- No prior cranial radiotherapy
- More than 14 days since prior investigational drugs for the primary malignancy
- More than 7 days since prior and no concurrent systemic therapy (e.g., chemotherapy,
immunotherapy, or biological therapy)
- At least 14 days since prior surgery for the current brain metastases
- No concurrent neurosurgery
- No concurrent emergent radiotherapy for brain metastases
- No concurrent investigational drugs
- Concurrent local therapy (e.g., surgery or radiotherapy) for the primary malignancy
allowed
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| NCT ID: |
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NCT00769444 |
| Primary Contact: |
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Principal Investigator
Kevin Camphausen, MD
NCI - Radiation Oncology Branch; ROB
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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