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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Study Time Perspective

RETROSPECTIVE

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Serono Limited, UK

INDUSTRY

Sponsor Role collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Merck Serono Research Site

Liverpool, , United Kingdom

Site Status

Merck Serono Research Site

London, , United Kingdom

Site Status

Merck Serono Research Site

Manchester, , United Kingdom

Site Status

Merck Serono Research Site

Southampton, , United Kingdom

Site Status

Countries

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United Kingdom

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.

Reference Type RESULT
PMID: 25703078 (View on PubMed)

Other Identifiers

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EMR062202-546

Identifier Type: -

Identifier Source: org_study_id

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