Neuropsychological Changes in Patients Receiving Radiation Therapy for Brain Metastases

Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Brain Metastasis
• Brain Neoplasms
• Cancer
• Neoplasm Metastasis
• Neoplasms, Second Primary

• NCT number: NCT01445483
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Start date: April 17, 2009