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Completed

NCT Number: NCT00007007

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

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.

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Key information

Conditions

Cognitive/Functional Effects Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Radiation Toxicity Wounds and Injuries

Age range

0 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

management of therapy complications

Procedure

quality-of-life assessment

Procedure

Primary outcomes

  1. Feasibility of performing a test battery of neurocognitive and quality of life measures

    Time frame: From registration to one month post radiation therapy

Sponsors and collaborators

Lead sponsor

Radiation Therapy Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
Mar 8, 2004
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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