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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 (RESECT)

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ClinicalTrials.gov Identifier: NCT01460745
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : February 4, 2014
Sponsor:
Collaborator:
Merck Serono Limited, UK
Information provided by (Responsible Party):
Merck KGaA

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.


Condition or disease
Metastatic Colorectal Cancer

Study Type : Observational
Actual Enrollment : 60 participants
Time Perspective: Retrospective
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 Start Date : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab




Primary Outcome Measures :
  1. Percentage of patients who undergo liver resection following downsizing chemotherapy with or without Erbitux [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. Percentage of liver resection outcomes R0, R1 and R2 [ Time Frame: 7 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460745


Locations
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, United Kingdom
Sponsors and Collaborators
Merck KGaA
Merck Serono Limited, UK
Investigators
Study Director: Medical Responsible Merck Serpno Limited, UK, an affiliate of Merck KGaA, Darmstadt, Germany

Publications of Results:
LIVER RESECTION RATE FOLLOWING DOWNSIZING CHEMOTHERAPY WITH CETUXIMAB IN METASTATIC COLORECTAL CANCER: UK REALWORLD STUDY. Malik H, Sherlock D, Pope I, Cameron I, Davidson B, Helmy S, Khan A, Berry D, Parkes L, Maddern J, Pulfer A, Cooper S Annals of oncology 2013 24(Suppl 4):iv38-121

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01460745     History of Changes
Other Study ID Numbers: EMR062202-546
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014

Keywords provided by Merck KGaA:
Erbitux
CRC
mCRC
Liver
Metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents