Neuropsychological Changes in Patients Receiving Radiation Therapy for Brain Metastases
- Conditions
- Brain MetastasisCancer
- Registration Number
- NCT01445483
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Neuropsychological function Completion of study To examine the relationship between neuropsychological function and survival in patients receiving radiation therapy for brain metastases
Test scores for: Hopkins Vrbl Learning Test recall; WAIS-III Digit Span; the WAIS-III Symbol Search; the Ruff 2 & 7 Selective Attn. The Trailmaking Tst Part B speed z-score; and the Grooved Pegboard Test dominant hand z-score Completion of study To identify the neuropsychological test scores which detect significant change in neuropsychological functioning in patients receiving radiation therapy for brain metastases
- Secondary Outcome Measures
Name Time Method Strengths and weaknesses in neuropsychological functioning completion of study To examine the strengths and weaknesses in neuropsychological functioning of patients with brain metastases after radiation therapy
RTOG RPA classification completion of study To examine the relationship between the RTOG RPA classification for brain metastasis survival and baseline neuropsychological functioning
North American Adult Reading Test-Short Form (NART-35), Hopkins Verbal Learning Test (HVLT), WAIS-III Digit Span subtest, WAIS-III Symbol Search subtest, Ruff 2 and 7 Selective Attention Test completion of study To further examine whether other measures from the following battery detect significant change in neuropsychological function or predict prognosis in this patient population
Neuropsychological functioning, brain lesions (e.g., number and volume), MRI abnormalities, biomarkers, and disease progression or recurrence completion of study To investigate the relationship between neuropsychological functioning, brain lesions (e.g., number and volume), MRI abnormalities, biomarkers, and disease progression or recurrence
neuron specific enolase (NSE), S100B, MMPs and VEGF completion of study To investigate the role of biomarkers, including neuron specific enolase (NSE), S100B, MMPs and VEGF as potential markers of brain injury and disease progression in the serum, plasma and urine of patients with brain metastases
Neuropsychological functioning completion of study To explore the neuropsychological functioning of patients with brain metastases treated with different therapies (e.g. chemotherapy, corticosteroids, complete surgical resection)
Baseline neuropsychological data completion of study To gather baseline neuropsychological data on patients with brain metastases for use as a reference in the development of new clinical trials involving this patient population in the ROB
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States