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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metastatic Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who undergo liver resection following downsizing chemotherapy with or without Erbitux |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of liver resection outcomes R0, R1 and R2 | The liver resection outcomes are defined as follows: R0: Absence of microscopic tumor invasion of the resection margins (tumour free margin ≥ 1mm); R1: Presence of microscopic tumor invasion of the resection margins (tumour free margin 0mm); R2: Presence of macroscopic positive margin after resection | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erbitux, CRC, mCRC, Liver, Metastases