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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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01460745 |
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Recruitment Status :
Completed
First Posted : October 27, 2011
Last Update Posted : February 4, 2014
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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.
| Condition or disease |
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| 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 |
- Percentage of patients who undergo liver resection following downsizing chemotherapy with or without Erbitux [ Time Frame: 7 months ]
- 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 |
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)
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
| 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 | |
| Study Director: | Medical Responsible | Merck Serpno Limited, UK, an affiliate of Merck KGaA, Darmstadt, Germany |
| Responsible Party: | Merck KGaA, Darmstadt, Germany |
| ClinicalTrials.gov Identifier: | NCT01460745 |
| Other Study ID Numbers: |
EMR062202-546 |
| First Posted: | October 27, 2011 Key Record Dates |
| Last Update Posted: | February 4, 2014 |
| Last Verified: | February 2014 |
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Erbitux CRC mCRC Liver Metastases |
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |