Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Neurocognitive function as measured by neurocognitive decline on a battery of tests
研究概览
简要总结
This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Assessment of neurocognitive function may help show that SRS preserves neurological function in patients with multiple brain metastases better than SBRT.
详细描述
PRIMARY OBJECTIVES:
I. Assessment of neurocognitive function at months 4.
SECONDARY OBJECTIVES:
I. Assessment of neurocognitive function at months 4 and 12 as measured by neurocognitive decline on a battery of tests.
II. Assessment of symptom burden, as measured by the M.D. Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically proven solid tumor malignancy (except for small cell lung cancer [SCLC], germ cell tumor)
- •Karnofsky performance status >= 60
- •1 to 10 brain metastases (mets) (no more than two lesions and/or cavities >= 3 cm in maximum diameter)
- •Maximum diameter of brain metastasis or resection cavity is 6 cm
- •Serum creatinine =< 3 mg/dL and creatinine clearance >= 30 ml/min
- •Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up; patients must be willing to complete neurocognitive assessments at pre-specified time points outlined in the protocol
- •Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 21 days prior to registration
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose
- •Patient able to provide his/her own written informed consent and speak English
排除标准
- •Patient with diagnosis of glioma, or other World Health Organization (WHO) grade II - IV primary brain tumor
- •Prior brain surgery =< 14 days prior to enrollment
- •Planned chemotherapy during radiosurgery
- •Leptomeningeal metastases
- •Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months
- •Pregnant women
研究组 & 干预措施
Supportive care (SRS/SBRT, neurocognitive testing)
Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.
干预措施: Cognitive Assessment (Procedure)
Supportive care (SRS/SBRT, neurocognitive testing)
Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.
干预措施: Stereotactic Radiosurgery (Radiation)
Supportive care (SRS/SBRT, neurocognitive testing)
Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
Supportive care (SRS/SBRT, neurocognitive testing)
Patients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Neurocognitive function as measured by neurocognitive decline on a battery of tests
时间窗: At 4 months
The proportion of patients with neurocognitive decline at 4 months post stereotactic radiosurgery (SRS) treatment in each group will be estimated using the sample proportion with the corresponding two-sided 95% confidence interval. The determination of neurocognitive decline will be based on a battery of tests: Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall, Delayed Recall, and Delayed Recognition, Controlled Oral Word Association (COWA), and the Trail Making Test (TMT) Parts A and B. The operative definition for neurocognitive decline in this study will be decline on at least one of these measures.
次要结局
- Overall survival (OS)(Up to 12 months)
- Local control as measured by magnetic resonance imaging(Up to 12 months)
- Progression free survival (PFS)(Up to 12 months)
- Change in symptom burden as measured by the MD Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT)(Baseline to up to 12 months)
- Quality adjusted survival and health outcomes as measured by the European Quality of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L)(Up to 12 months)
- Change in neurocognitive function as measured by neurocognitive decline on a battery of tests conducted by the primary investigator or a trained member of the clinical team(Baseline to up to 12 months)
- Incidence of adverse events graded according to the Common Terminology Criteria for Adverse Events version 5.0(Up to 30 days after SRS)