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 (RESECT)

February 3, 2014 updated by: Merck KGaA, Darmstadt, Germany

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom
        • Merck Serono Research Site
      • Liverpool, United Kingdom
        • Merck Serono Research Site
      • London, United Kingdom
        • Merck Serono Research Site
      • Manchester, United Kingdom
        • Merck Serono Research Site
      • Southampton, United Kingdom
        • Merck Serono Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of liver resection outcomes R0, R1 and R2
Time Frame: 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
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono Limited, UK

Investigators

  • Study Director: Medical Responsible, Merck Serpno Limited, UK, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 25, 2011

First Submitted That Met QC Criteria

October 25, 2011

First Posted (Estimate)

October 27, 2011

Study Record Updates

Last Update Posted (Estimate)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR062202-546

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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