A Pilot Neoadjuvant Clinical Trial With Evaluation of Molecular Effects With Sorafenib Tosylate for Patients With Stage II or Greater Renal Cell Carcinoma
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of subjects experiencing adverse events while taking sorafenib prior to nephrectomy
研究概览
简要总结
RATIONALE: Sorafenib 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 sorafenib 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 and how well sorafenib works in treating patients undergoing surgery for stage II, stage III, or stage IV kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety and feasibility of systemic sorafenib tosylate therapy when given prior to definitive nephrectomy in patients with stage II-IV renal cell carcinoma (RCC).
Secondary
- Determine all levels of response in primary renal tumors of patients treated with this drug.
- Assess effects of this drug on gene expression, protein expression, and metabolic profile using tumor tissue samples from these patients.
- Identify biomarkers or biomarker patterns associated with RCC or this drug 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
Single Arm Study
干预措施: sorafenib tosylate (Drug)
结局指标
主要结局
Number of subjects experiencing adverse events while taking sorafenib prior to nephrectomy
时间窗: 8 weeks
Adverse events will be assessed (graded) using CTCAE criteria
Feasibility of neoadjuvant systemic therapy prior to nephrectomy
时间窗: 8 weeks
Feasibility will be measured by the proportion of patients who complete therapy
次要结局
- Response in primary renal tumors(8 weeks)
- Effects of sorafenib tosylate therapy on gene expression, protein expression, and metabolic profile(8 weeks)