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| Tracking Information | |||||
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| First Received Date ICMJE | October 8, 2008 | ||||
| Last Updated Date | August 25, 2009 | ||||
| Start Date ICMJE | June 2008 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00769444 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neuropsychological Measures in Patients Undergoing Radiation Therapy for Brain Metastases | ||||
| Official Title ICMJE | A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases | ||||
| Brief Summary | 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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| Detailed Description | OBJECTIVES: Primary
Secondary
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, 2, 4, 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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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00769444 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000615194, NCI-08-C-0214 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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