Neuropsychological Changes in Patients Receiving Radiation Therapy for Brain Metastases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01445483|
Recruitment Status : Recruiting
First Posted : October 3, 2011
Last Update Posted : August 9, 2018
- 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.
- 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.
- Patients 18 years of age or older who have cancer that has spread to the brain.
- 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.
|Condition or disease|
|Brain Metastasis Cancer|
- 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. Theses 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.
- 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.
- Patients age 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.
- 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), and then after radiation at one month post-baseline (2 weeks after radiation therapy), then at 3, and 6 months, and then every 3 months for up to 12 months after baseline.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases|
|Study Start Date :||September 15, 2008|
- To identify the neuropsychological test scores which detect significant change in neuropsychological functioning in patients receiving radiation therapy for brain metastases. [ Time Frame: Completion of study ]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 [ Time Frame: Completion of study ]To examine the relationship between neuropsychological function and survival in patients receiving radiation therapy for brain metastases
- To further examine whether other measures from the following battery detect significant change in neuropsychological function or predict prognosis in this patient population. [ Time Frame: Completion of study ]
- To examine the relationship between the RTOG RPA classification for brain metastasis survival and baseline neuropsychological functioning. [ Time Frame: Completion of study ]
- To examine the strengths and weaknesses in neuropsychological functioning of patients with brain metastases after radiation therapy. [ Time Frame: Completion of Study ]
- To explore the neuropsychological functioning of patients with brain metastases treated with different therapies (e.g. chemotherapy, corticosteroids, complete surgical resection). [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Completion of Study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445483
|Contact: Theresa Cooley-Zgela, R.N.||(240) email@example.com|
|Contact: DeeDee K Smart, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||DeeDee K Smart, M.D.||National Cancer Institute (NCI)|