Clinical trial NCT01460745: 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
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: Erbitux
CRC
mCRC
Liver
Metastases
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Limited, UK
First posted: 2011-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of patients who undergo liver resection following downsizing chemotherapy with or without Erbitux
timeFrame: 7 months
Secondary outcomes:
measure: Percentage of liver resection outcomes R0, R1 and R2
timeFrame: 7 months
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Merck Serono Research Site
city: Liverpool
country: United Kingdom
facility: Merck Serono Research Site
city: London
country: United Kingdom
facility: Merck Serono Research Site
city: Manchester
country: United Kingdom
facility: Merck Serono Research Site
city: Southampton
country: United Kingdom
facility: Merck Serono Research Site
Study officials:
affiliation: Merck Serpno Limited, UK, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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.