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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cognitive/Functional Effects, Metastatic Cancer, Radiation Toxicity

Intervention / Treatment
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* Procedure: management of therapy complications
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole brain radiation therapy + neurocognitive assessments<br>Whole brain radiation therapy (WBRT) with neurocognitive assessments done pre and post WBRT. | Procedure: management of therapy complications<br> <br> Procedure: quality-of-life assessment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of performing a test battery of neurocognitive and quality of life measures |  | From registration to one month post radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumors metastatic to brain, radiation toxicity, cognitive/functional effects