Medical and Economical Evaluation of Contrast-enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 24
- 主要终点
- ratio cost/benefit of a strategy of therapeutic monitoring by contrast-enhanced ultrasound
研究概览
简要总结
Bevacizumab, an anti-angiogenic agent, plus fluorouracil based chemotherapy is considered a new standard for the treatment of metastatic colorectal cancer. Contrast-enhanced ultrasound with gas-encapsulated microbubbles can be used to assess tumour vascularity, particularly hepatic metastases, and may become a useful tool for monitoring anti-angiogenic therapies. The aim of this prospective, multicenter, non-randomized study is to evaluate the usefulness of hepatic contrast-enhanced ultrasound to predict response to bevacizumab based chemotherapy in patient with metastatic colorectal cancer. The primary objective of this study is to compare the functional vascular changes related to bevacizumab based chemotherapy and evaluated by hepatic contrast-enhanced ultrasound with classic RECIST criteria. The secondary objectives are to do a characterization of the pharmacokinetic of bevacizumab, to explore the pharmacodynamic effects of bevacizumab on functional vascular changes of hepatic metastases evaluated by hepatic contrast-enhanced ultrasound and to analyze the possible relationships between treatment efficacy or toxicity and constitutional gene polymorphisms linked to the bevacizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed colorectal tumor
- •first line treatment by a bevacizumab based chemotherapy
- •Target hepatic metastases of size lower than 5 cm and higher than 5 mm detected by conventional ultrasonography and CT or MRI
- •Life expectancy > 2 months
- •OMS status =< 2
- •Major surgery, open biopsy, or significant traumatic injury within 28 days prior to Day 0
- •informed consent signed
排除标准
- •no target hepatic lesion detected by conventional ultrasonography
- •Prior bevacizumab treatment
- •Prior chemotherapy treatment for advanced disease
- •Clinically significant cardiac disease (e.g. myocardial infarction or stroke within 12 months, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure not well controlled with medication, endocarditis and prosthetic valve) and any contraindications in sulphur hexafluoride administration
- •Blood pressure >= 180/110 mmHg
- •Daily and chronic treatment by aspirin or AINS
- •Anticipation of need for major surgical procedure within 7 days prior day 0
- •Urine protein > 1g/24 Hours
- •Any contraindication in enhancing bevacizumab treatment
- •Serious, uncontrolled, concurrent infection(s) or illness(es)
- •pregnant and lactating woman
结局指标
主要结局
ratio cost/benefit of a strategy of therapeutic monitoring by contrast-enhanced ultrasound
时间窗: 2 months
functional vascular changes in tumour vascularity of hepatic metastases
时间窗: 2 months
Pharmacokinetic of bevacizumab between each cure of bevacizumab based chemotherapy
时间窗: 2 months
evaluation of the response to bevacizumab based chemotherapy by RECIST criteria
时间窗: 2 months
次要结局
- survival time(2 years)
- bevacizumab-related toxicity(2 months)
- time to disease progression(2 years)
- response duration(2 years)