A Pilot Study of Neoadjuvant SUNITINIB MALATE (Sunitinib) in Patients With Renal Cell Carcinoma Undergoing Nephrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety of Sunitinib Malate (SM)
研究概览
简要总结
RATIONALE: Sunitinib 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. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying the side effects of giving sunitinib before surgery and to see how well it works in treating patients with localized or metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of sunitinib malate in patients with localized or metastatic renal cell carcinoma.
- Determine the safety of surgery after 90 days of treatment with sunitinib malate in these patients.
Secondary
- Determine response of these patients after 90 days of treatment with sunitinib malate.
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
Arm 1
干预措施: sunitinib malate (Drug)
Arm 1
干预措施: neoadjuvant therapy (Procedure)
Arm 1
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
Safety of Sunitinib Malate (SM)
时间窗: 90 days
Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.
Safety of Surgery After 90 Days of Treatment With SM
时间窗: 90 days
Incident Rate: Intraoperative Complication Rate
次要结局
- Response Rate After 90 Days of Treatment With SM(90 days)