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

This study is ongoing, but not recruiting participants.

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
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

U.S. FDA Resources

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

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

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

Publications of Results:

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.

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.

Study ID Numbers:	CDR0000068366, RTOG-BR-0018, RTOG-DEV-1053
Study First Received:	December 6, 2000
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00007007
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult tumors metastatic to brain
radiation toxicity
quality of life
cognitive/functional effects

Study placed in the following topic categories:

Neoplasm Metastasis
Quality of Life
Central Nervous System Neoplasms
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009