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
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
Neoplasms
Neoplasms, Second Primary
Radiation Injuries
Neoplastic Processes
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014