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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00007007
First received: December 6, 2000
Last updated: October 31, 2013
Last verified: October 2013
  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: Open Label
Official Title: A Feasibility Study of Neurocognitive Evaluation in Patients Treated for Brain Metastases

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: November 2000
Primary Completion Date: October 2007 (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

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
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, see Learn About Clinical Studies.

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

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

Additional 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
Study First Received: December 6, 2000
Last Updated: October 31, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 23, 2014