A Retrospective Review of Liver Resection Rate in Metastatic Colorectal Cancer Patients Following Downsizing Treatment With Chemotherapy Plus Cetuximab in Normal UK National Health Service Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of patients who undergo liver resection following downsizing chemotherapy with or without Erbitux
研究概览
简要总结
This study is a multi-centre retrospective observational research study which will be conducted in UK centres with specialised liver surgical services.
The study will involve retrospective review of medical records of patients with metastatic colorectal cancer (mCRC) with metastases confined to the liver, defined locally as unresectable without downsizing therapy at first review by a Hepatobiliary Multi Disciplinary Team (HPB MDT). Erbitux is available for use in combination with chemotherapy as a downsizing treatment for patients with previously unresectable metastases.
The study aims to examine liver resection rates achieved in normal clinical practice in order to inform National Health Service (NHS) clinical and policy decision making and to further understanding of how cetuximab is used in a standard clinical setting. This study intends to estimate the proportion of patients with unresectable liver metastases who undergo liver resection following downsizing treatment with chemotherapy plus cetuximab.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
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
- •Patients who had mCRC and metastases confined to the liver
- •Patients in whom downsizing regimens are recommended
- •Patients in whom downsizing treatment included cetuximab
- •Patients referred to Hepatobiliary Multi Disciplinary Team (HPB MDT) between 01.01.2010-31.03.2011
排除标准
- •Patients who are considered to have immediately resectable liver metastases as determined by the HPB MDT
- •Patients who are considered to have never resectable liver metastases as determined by the HPB MDT
- •Patients who were aged less than 18 at date of initiation of cetuximab
- •Patients who are enrolled in a clinical trial during the data collection period
- •Patients who are receiving private healthcare for the treatment of mCRC
- •According to Summary of Product Characteristics (SmPC)
结局指标
主要结局
Percentage of patients who undergo liver resection following downsizing chemotherapy with or without Erbitux
时间窗: 7 months
次要结局
- Percentage of liver resection outcomes R0, R1 and R2(7 months)