⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Neuropsychological Changes in Patients Receiving Radiation Therapy for Brain Metastases

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Neuropsychological Changes in Patients Receiving Radiation Therapy for Brain Metastases

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

Study ID: NCT01445483

Interventions

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Contact Details

Name: DeeDee K Smart, M.D.

Affiliation: National Cancer Institute (NCI)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: