NCT01445483

Neuropsychological Changes in Patients Receiving Radiation Therapy for Brain Metastases

A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: * There are no standardized sets of tests to measure changes in neuropsychological functioning in patients treated for brain metastasis (cancer that has spread beyond the original site to the brain). * Neuropsychological function has an important effect on quality of life and should be included when determining treatment options. Objectives: * To find out if there is a change in patients cognitive (thinking) and daily functioning after standard radiation treatment for brain metastasis that can be measured with tests. * To see if any changes on these tests are related to patients response to radiation therapy. Eligibility: \- Patients 18 years of age or older who have cancer that has spread to the brain. Design: * Patients receive a 2-week course of radiation therapy to the brain, given daily 5 days a week. Some patients may require stereotactic radiosurgery (an additional boost of radiation therapy to specific sites of brain metastasis). * Patients have the following evaluations before and after treatment to determine changes in cognition and functioning: * Neuropsychological testing to measure cognitive (thinking) abilities like memory, attention, processing speed, and reading, and fine motor skills. * Questionnaires to assess quality of life and daily living skills. * Patients have MRI scans and blood and urine tests. * At the completion of radiation treatment, patients return to the clinic for follow-up visits at 1, 2, 4, 6, 9 and 12 months for blood and urine tests, physical examination, MRI of the brain, neuropsychological testing and assessments of quality of life and daily living skills.

Detailed description

Background: * Metastatic brain tumors occur more frequently than primary brain tumors and occur in approximately 25 percent of patients who die of cancer each year. * The Radiation Therapy Oncology Group (RTOG) developed three prognostic classes using a recursive partitioning analysis (RPA) of a large database. These classes are based on Karnofsky Performance Status (KPS), age and disease status. * The RTOG RPA classes do not include neuropsychological function as a measure of outcome. * There is no consensus of standardization of test selection to measure changes in neuropsychological functioning in this patient population. * Neuropsychological function has an important effect on quality of life and should be included when determining prognosis and treatment options for patients. * Neuropsychological functioning is important when determining the effects of treatments and for measuring outcomes in clinical trials. Objectives: * To identify the neuropsychological test scores which detect significant change in neuropsychological functioning in patients receiving radiation therapy for brain metastases. * To examine the relationship between neuropsychological function and survival in patients receiving radiation therapy for brain metastases. Eligibility: * Patients aged 18 years and older. * Pathologically confirmed primary malignancy with at least one intraparenchymal brain metastasis as identified on brain MRI scan with intravenous contrast. * The patient must communicate in English in order to complete the neuropsychological evaluations. Design: * This is a longitudinal study that will administer serial neuropsychological assessments to patients with brain metastases who receive radiation therapy. * Patients will undergo a battery of neuropsychological tests prior to radiotherapy (WBRT or WBRT followed by SRS), 2 weeks after completion of radiation therapy, then every 3 months for up to 12 months. * The test battery will involve approximately 40 minutes of direct cognitive testing and 15 minutes of questionnaires. There will be three cohorts of 20 patients each for a total of 60 patients. The three cohorts will be made up of differing histologies and will be sorted on the basis of their RTOG RPA Class.

Conditions

• Brain Metastasis
• Cancer

Timeline

• Start date: 2009-04-17
• First posted: 2011-10-03
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States