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

Metastatic Colorectal Cancer Clinical Trial

— RESECT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460745
• Other study ID #: EMR062202-546
• Status: Completed
• Phase: N/A
• First received: October 25, 2011
• Last updated: February 3, 2014
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono Limited, UK

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. Eu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who undergo liver resection following downsizing chemotherapy with or without Erbitux		7 months	No
Secondary	Percentage of liver resection outcomes R0, R1 and R2	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	No