SUNDANCE Trial: Phase II Trial of Sunitinib as Maintenance Therapy After Stereotactic Radiosurgery in Patients With 1-3 Newly Diagnosed Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Central Nervous System (CNS) Progression-free Survival Rate
研究概览
简要总结
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib malate works after stereotactic radiosurgery in treating patients with newly diagnosed brain metastases.
详细描述
OBJECTIVES:
Primary
- Determine the CNS progression-free survival rate in patients with 1-3 newly diagnosed brain metastases treated with sunitinib malate after stereotactic radiosurgery (SRS).
Secondary
- Determine the rate of local (site of SRS treatment) failure at 12 months in these patients.
- Determine the median time to CNS disease progression in these patients.
- Determine the overall survival of these patients.
- Determine the time to progression of systemic disease in these patients.
- Evaluate the safety of sunitinib malate when administered after SRS in these patients.
- Assess the neurocognitive effects of SRS followed by sunitinib malate in these patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sunitinib malate
Oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life.
干预措施: sunitinib malate (Drug)
Sunitinib malate
Oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life.
干预措施: cognitive assessment (Other)
结局指标
主要结局
Central Nervous System (CNS) Progression-free Survival Rate
时间窗: 6 months after stereotactic radiosurgery (SRS)
The number of subjects surviving at least six months from SRS without progressive disease anywhere in the brain (local or regional failure), assessed by the McDonald's standard criteria.Progressive neurologic abnormalities not explained by causes unrelated to tumor progression (e.g. anticonvulsant or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the size of the tumor by MRI/CT scan.
次要结局
- Overall Survival(12 months from SRS)
- Central Nervous System (CNS) Progression-free Survival Rate(12 months after stereotactic radiosurgery (SRS))
- Rate of Local Failure at 12 Months(12 months)
- Median Time to CNS Disease Progression(up to12 months from SRS)
- Neurocognitive Effects(at 2 months after treatment)
- Safety and Tolerability(3 years from study start)
- Time to Progression(at 3 yrs from SRS)