Metastatic Colorectal CancerRESECTNCT01460745
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
An observational study of Metastatic Colorectal Cancer, run by Merck KGaA, Darmstadt, Germany at 5 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 60 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Nov 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Merck Serono Research Site
Bristol
Merck Serono Research Site
Liverpool
Merck Serono Research Site
London
Merck Serono Research Site
Manchester
Merck Serono Research Site
Southampton
About this study
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
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who undergo liver resection following downsizing chemotherapy with or without Erbitux
Measured: 7 months
Secondary outcomes (1)
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
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono Limited, UK
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Serpno Limited, UK, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460745
- Sponsor's protocol ID
- EMR062202-546
- Acronym
- RESECT
- Status last verified
- Feb 2014
- First submitted
- 25 Oct 2011
- Last updated
- 4 Feb 2014
- Results posted
- No
Publications
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.
PubMed 25703078
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01460745
- Acronym / sponsor ID
- RESECT / EMR062202-546
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Erbitux, CRC, mCRC, Liver, Metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono Limited, UK
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients who undergo liver resection following downsizing chemotherapy with or without Erbitux
Time frame: 7 months
1 secondary outcome
Percentage of liver resection outcomes R0, R1 and R2
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
- Results publication: PubMed 25703078Malik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck Serpno Limited, UK, an affiliate of Merck KGaA, Darmstadt, Germany
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Merck KGaA, Darmstadt, Germany at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who undergo liver resection following downsizing chemotherapy with or without Erbitux (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01460745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2014.