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Evaluation of Memory Skills in Patients Receiving Radiation Therapy for Brain Metastases

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ClinicalTrials.gov Identifier: NCT00007007
Recruitment Status : Completed
First Posted : March 8, 2004
Last Update Posted : March 27, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

December 6, 2000
March 8, 2004
March 27, 2015
November 2000
December 2004   (Final data collection date for primary outcome measure)
Feasibility of performing a test battery of neurocognitive and quality of life measures [ Time Frame: From registration to one month post radiation therapy ]
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Complete list of historical versions of study NCT00007007 on ClinicalTrials.gov Archive Site
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Evaluation of Memory Skills in Patients Receiving Radiation Therapy for Brain Metastases
A Feasibility Study of Neurocognitive Evaluation in Patients Treated for Brain Metastases

RATIONALE: Assessment of patients undergoing radiation therapy may help to determine the effects of the treatment and may help improve cancer treatment.

PURPOSE: This clinical trial is studying the memory skills in patients receiving radiation therapy for brain metastases.

OBJECTIVES: I. Determine the feasibility of performing a test battery consisting of five neurocognitive measures and a quality of life instrument following radiotherapy in patients with brain metastases.

OUTLINE: Patients undergo radiotherapy 5 days a week for 3 weeks. Quality of life and neurocognitive function is assessed before study, at completion of radiotherapy, and at 1 month after completion of radiotherapy. Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5 months.

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Intervention Model: Single Group Assignment
Masking: None (Open Label)
  • Cognitive/Functional Effects
  • Metastatic Cancer
  • Radiation Toxicity
  • Procedure: management of therapy complications
  • Procedure: quality-of-life assessment
Experimental: Whole brain radiation therapy + neurocognitive assessments
Whole brain radiation therapy (WBRT) with neurocognitive assessments done pre and post WBRT.
  • Procedure: management of therapy complications
  • Procedure: quality-of-life assessment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2004
December 2004   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS: Histologically proven primary malignancy No primary site of hematopoietic origin (leukemia) No leptomeningeal involvement At least 1 measurable brain metastasis by CT or MRI

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception Neurological function classification 0-2 No major medical illnesses or psychiatric impairments that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the brain Surgery: Not specified

Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: William F. Regine, MD Lucille P. Markey Cancer Center at University of Kentucky
Radiation Therapy Oncology Group
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP