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| Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00007007 |
Purpose
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.
| Condition | Intervention |
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Brain and Central Nervous System Tumors Cancer-Related Problem/Condition |
Procedure: management of therapy complications Procedure: quality-of-life assessment |
| MedlinePlus related topics: | Cancer Memory |
| Study Type: | Interventional |
| Study Design: | Other |
| Official Title: | A Feasibility Study of Neurocognitive Evaluation in Patients Treated for Brain Metastases |
| Study Start Date: | November 2000 |
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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations |
Show 241 Study Locations |
| Radiation Therapy Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | William F. Regine, MD | Lucille P. Markey Cancer Center at University of Kentucky |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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Kwok Y, Won M, Regine WF, et al.: Neurocognitive impact of whole brain radiation on patients with brain metastases: secondary analysis of RTOG BR-0018. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-184, S103, 2007.
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Regine WF, Schmitt FA, Scott CB, Dearth C, Patchell RA, Nichols RC Jr, Gore EM, Franklin RL 3rd, Suh JH, Mehta MP. Feasibility of neurocognitive outcome evaluations in patients with brain metastases in a multi-institutional cooperative group setting: results of Radiation Therapy Oncology Group trial BR-0018. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1346-52.
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| Study ID Numbers: | CDR0000068366, RTOG-BR-0018, RTOG-DEV-1053 |
| First Received: | December 6, 2000 |
| Last Updated: | October 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00007007 |
| Health Authority: | United States: Federal Government |
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