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

Tracking Information

First Received Date ^ICMJE

December 6, 2000

Last Updated Date

August 29, 2009

Start Date ^ICMJE

November 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00007007 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Feasibility Study of Neurocognitive Evaluation in Patients Treated for Brain Metastases

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other

Condition ^ICMJE

Cognitive/Functional Effects
Metastatic Cancer
Radiation Toxicity

Intervention ^ICMJE

Procedure: management of therapy complications
Procedure: quality-of-life assessment

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00007007

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068366, RTOG-BR-0018, RTOG-DEV-1053

Study Sponsor ^ICMJE

Radiation Therapy Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

William F. Regine, MD

Lucille P. Markey Cancer Center at University of Kentucky

Information Provided By

National Cancer Institute (NCI)

Verification Date

November 2007

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