The Vascular and Metabolic Effects of Sunitinib in Patients With Metastatic Renal Cell Carcinoma
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
- Endothelial function
研究概览
简要总结
Rationale: The introduction of angiogenesis inhibitors, like sunitinib and bevacizumab, has improved the outcome of patients with several types of cancer remarkably. However, their application is hampered by side effects, such as development of hypertension with consequences for renal and cardiac function. Moreover patients treated with angiogenesis inhibitors may suffer from weight loss, and insulin sensitivity during treatment appears to change. The treatment with angiogenesis inhibitors, will improve life expectancy of patients with various cancer diagnoses and therefore the clinical relevance of both short term and long lasting adverse events will translate into reduced quality of life. In addition, premature withdrawal of angiogenesis inhibitors due to side effects may result in lower response, shorter duration of response and possibly a shorter survival. Therefore, adequate treatment of above mentioned side effects in patients treated with angiogenesis inhibitors is of relevance for the response rate, the duration of progression free survival and overall survival and for quality of life.
Mechanistic insight in the pathogenesis of these side effects will help optimizing treatment.
Objective: The primary objective of the study is to investigate the effect of sunitinib on endothelial function, insulin sensitivity, renal function and renal blood flow.
Study design: Single-centre non randomized observational study Study population: 30 Patients (>18 years old) starting with sunitinib as treatment for metastatic renal cell carcinoma.
研究设计
- 研究类型
- Observational
- 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
- •Subject is able and willing to sign the Informed Consent Form
- •Age 18 years or older
- •WHO performance status 0-2
- •Life expectancy ≥ 12 weeks
- •mRCC patients in which the treatment of choice is sunitinib
排除标准
- •Use of corticosteroids
- •Any evidence of severe or uncontrolled diseases other than renal cell carcinoma eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease.
- •Known risk of the patient transmitting HIV, hepatitis B or C via infected blood
- •Patients being treated with oral anticoagulants if to be included in group A.
结局指标
主要结局
Endothelial function
时间窗: 2 weeks
Group A: Vasomotor response to intra-arterially administered doses of acetylcholine and nitroprusside before and after start sunitinib
Insulin sensitivity
时间窗: 2 weeks
Group B: Insulin sensitivity measured by hyperinsulinemic euglycemic clamp before and after start sunitinib
GFR and renal perfusion flow
时间窗: 2 weeks
Group C: GFR and RPF measured by PAH and inulin clearance before and after start of treatment with sunitinib
次要结局
- Weight(3 months)
- Blood pressure(3 months)
- Laboratory evaluations(12 weeks)
研究者
G. Rongen
Prof. dr. Rongen
Radboud University Medical Center