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
NCT ID: NCT01460745
Last Updated: 2014-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2011-11-30
2012-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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Merck Serono Limited, UK
INDUSTRY
Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Serpno Limited, UK, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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Merck Serono Research Site
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
Countries
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References
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Malik H, Khan AZ, Berry DP, Cameron IC, Pope I, Sherlock D, Helmy S, Byrne B, Thompson M, Pulfer A, Davidson B. Liver resection rate following downsizing chemotherapy with cetuximab in metastatic colorectal cancer: UK retrospective observational study. Eur J Surg Oncol. 2015 Apr;41(4):499-505. doi: 10.1016/j.ejso.2015.01.032. Epub 2015 Feb 7.
Other Identifiers
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EMR062202-546
Identifier Type: -
Identifier Source: org_study_id
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