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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00007007
First received: December 6, 2000
Last updated: August 29, 2009
Last verified: November 2007
History of Changes
  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
Cognitive/Functional Effects
Metastatic Cancer
Radiation Toxicity
 Procedure: management of therapy complications
Procedure: quality-of-life assessment

Study Type: Interventional
Official Title: A Feasibility Study of Neurocognitive Evaluation in Patients Treated for Brain Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer Memory
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2000
Detailed Description:

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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007007

  Show 241 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: William F. Regine, MD Lucille P. Markey Cancer Center at University of Kentucky
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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.

ClinicalTrials.gov Identifier: NCT00007007     History of Changes
Other Study ID Numbers: CDR0000068366, RTOG-BR-0018, RTOG-DEV-1053
Study First Received: December 6, 2000
Last Updated: August 29, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
tumors metastatic to brain
radiation toxicity
cognitive/functional effects

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Radiation Injuries
 Neoplastic Processes
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013