A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases
概览
- 阶段
- 不适用
- 干预措施
- 1/Cohort 1
- 疾病 / 适应症
- Brain Metastasis
- 发起方
- National Cancer Institute (NCI)
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Neuropsychological function
- 状态
- 已完成
- 最后更新
- 昨天
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •INCLUSION CRITERIA:
- •Patients must be 18 years of age or older.
- •Pathologically confirmed primary malignancy with at least one intraparenchymal brain metastasis as identified on brain MRI scan with intravenous contrast.
- •Cohort 1 (N=20): KPS greater than 70; Age less than or equal to 65; controlled primary tumor and no extracranial metastases.
- •Cohort 2 (N=20): KPS greater than 70 and at least one of the following: age greater than 65, uncontrolled or synchronous primary disease, or extracranial metastases
- •Cohort 3 (N=20): KPS less than 70
- •Patient must have a primary medical or surgical oncologist in the community or at NCI who is willing to collaborate with the ROB staff in the clinical management of the patient.
- •All patients must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study BEFORE any of the protocol related studies are preformed (this does not include routine laboratory tests or imaging studies required to establish eligibility).
- •Subjects of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study.
排除标准
- •Cognitively impaired patients who cannot give informed consent, including patients assigned a power of attorney for medical decisions.
- •Inability to communicate in the English language.
- •Pre- existing or active psychiatric or neurologic impairments, not caused by the brain metastasis, which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol.
- •Prior Therapy
- •Patients must not have been treated for a previous brain metastasis.
- •Patients must not have had previous cranial radiation.
- •Patients must not undergo treatment with an investigational drug for the primary disease within 7 days of baseline neuropsychological testing.
- •Patients must not receive systemic therapy within 7 days prior to baseline neuropsychological testing.
- •Patients who have had surgery for their current brain metastasis must wait at least 7 days before baseline neuropsychological testing.
- •Concurrent Therapy
研究组 & 干预措施
1/Cohort 1
KPS\>70; Age =65; controlled primary tumor and no extracranial metastases
2/Cohort 2
KPS\>70 and at least one of the following: age \>65, uncontrolled or synchronous primary disease, or extracranial metastases
3/Cohort 3
KPS\<70
结局指标
主要结局
Neuropsychological function
时间窗: 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
时间窗: Completion of study
To identify the neuropsychological test scores which detect significant change in neuropsychological functioning in patients receiving radiation therapy for brain metastases
次要结局
- Strengths and weaknesses in neuropsychological functioning(completion of study)
- RTOG RPA classification(completion of study)
- 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)
- Neuropsychological functioning, brain lesions (e.g., number and volume), MRI abnormalities, biomarkers, and disease progression or recurrence(completion of study)
- neuron specific enolase (NSE), S100B, MMPs and VEGF(completion of study)
- Neuropsychological functioning(completion of study)
- Baseline neuropsychological data(completion of study)