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

Completed

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT01460745
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-27
• Study Start: 2011-11
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients who undergo liver resection following downsizing chemotherapy with or without Erbitux	7 months

Secondary Outcome Measures

Name	Time	Method
Percentage of liver resection outcomes R0, R1 and R2	7 months	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

Trial Locations

Locations (1)

Merck Serono Research Site; 🇬🇧 Southampton, United Kingdom