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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00007007
First Posted: March 8, 2004
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
  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
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Feasibility Study of Neurocognitive Evaluation in Patients Treated for Brain Metastases

Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Feasibility of performing a test battery of neurocognitive and quality of life measures [ Time Frame: From registration to one month post radiation therapy ]

Enrollment: 59
Study Start Date: November 2000
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00007007     History of Changes
Other Study ID Numbers: RTOG-BR-0018
CDR0000068366
RTOG-DEV-1053
First Submitted: December 6, 2000
First Posted: March 8, 2004
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by Radiation Therapy Oncology Group:
tumors metastatic to brain
radiation toxicity
cognitive/functional effects

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