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

NCT01460745 | Completed

• 1 other identifier: EMR062202-546
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Colorectal Cancer

Keywords

Erbitux; CRC; mCRC; Liver; Metastases

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who undergo liver resection following downsizing chemotherapy with or without Erbitux

  7 months

Secondary Outcomes (1)

• Percentage of liver resection outcomes R0, R1 and R2

  7 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Limited, UK: collaborator

Study Sites (5)

Merck Serono Research Site

Bristol, United Kingdom

Location

Merck Serono Research Site

Liverpool, United Kingdom

Location

Merck Serono Research Site

London, United Kingdom

Location

Merck Serono Research Site

Manchester, United Kingdom

Location

Merck Serono Research Site

Southampton, United Kingdom

Location

Related 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. Eur J Surg Oncol. 2015 Apr;41(4):499-505. doi: 10.1016/j.ejso.2015.01.032. Epub 2015 Feb 7.

  PMID: 25703078 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Responsible

  Merck Serpno Limited, UK, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 27, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

GB (5)