An Imaging and Histopathologic Study to Predict Response to Sunitinib Therapy in Patients With Metastatic or Locally Advanced Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
Rationale: Diagnostic procedures, such as MRI, may help doctors predict a patient's response to treatment and help plan the best treatment.
Purpose: This clinical trial is studying MRI in predicting response to sunitinib malate in patients with locally advanced or metastatic kidney cancer.
详细描述
Primary Objectives:
I. To correlate tumor vascular permeability by DCE-MRI with clinical outcome for patients treated with sunitinib (PFS).
II. To correlate genetic and histologic characteristics of the primary tumor with vascular permeability by DCE-MRI.
Secondary Objectives:
I. To correlate genetic and histologic characteristics of the primary tumor with clinical outcome for patients treated with sunitinib.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 I
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.
干预措施: mutation analysis (Genetic)
Arm I
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.
干预措施: pharmacological study (Other)
Arm I
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.
干预措施: dynamic contrast-enhanced magnetic resonance imaging (Procedure)
Arm I
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.
干预措施: sunitinib malate (Drug)
Arm I
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.
干预措施: immunohistochemistry staining method (Other)
Arm I
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI at baseline and after the first 4 weeks of sunitinib malate.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Progression-free survival
Correlation of tumor vascular permeability as measured by dynamic contrast-enhanced MRI with clinical outcome and with tumor angiogenesis as measured by immunohistochemistry (IHC)
次要结局
- Tumor regression as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria