Liver MetastasisCLIMBNCT02218801
A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program
An observational study of Liver Metastasis and Colorectal Carcinoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 16 sites in 12 countries.
Trial summary
This prospective database has two main objectives; to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastasis, Colorectal Carcinoma
- What is being tested?
- Evaluation of treatment for liver metastasis
- How many people
- 219 participants
- Where
- 16 sitesin 12 countries
- Study dates
- May 2015to Feb 2021
- How long will I take part?
- 2 Years
- 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: Patients with liver metastasis of colorectal adenocarcinoma (unresectable, borderline resectable or initially unresectable)
Who may be able to join
- With histologically proven colorectal adenocarcinoma with liver metastasis.
- With unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer assessed by a clinician or by a multi-disciplinary tumor board (MDT).
- Unresectable is defined as no possibility of completely resecting all tumor due to size, location or number of deposits.
- Borderline is defined as potentially operable but technically or biologically more challenging to resect as evaluated by the MDT.
- Initially unresectable is defined as metastasis that have been down-sized after conversion chemotherapy and evaluated by the MDT to be resectable
- discussed by a multidisciplinary team before surgery.
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- Participants of the MDT must include at least one liver surgeon, one radiologist and one oncologist. They will determine the resectability of the CRLM according to local practice.
- With a possibility of a surgical procedure (resection with or without portal vein embolization, intraoperative local ablative technique or a combined approach) assessed during the MDT.
- Age ≥ 18 years.
- Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
Who cannot join
- Any psychological, familial, or sociological condition potentially hampering understanding of the research project.
- Any other malignancy other than in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 5 years)
Trial locations and contacts
16 sites in 12 countries.
16 sites in 12 countries
Austria2 sites
Innsbruck Universitaetsklinik
Innsbruck, 6020
Der Wiener Krankenanstaltenverbund - Krankenanstalt Rudolfstiftung
Vienna, 1030
Germany2 sites
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307
Klinikum Der J.W. Goethe Universitaet
Frankfurt am Main, 60590
Netherlands2 sites
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam, 1066
Leiden University Medical Centre
Leiden, 2300
United Kingdom1 site
Aintree University Hospital NHS Trust
Liverpool, GB L9 7AL
About this study
This prospective database has two main objectives;
- to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer.
- to establish baseline quality parameters for different surgical strategies for unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM) patients.
- Conditions
- Liver Metastasis, Colorectal Carcinoma
- Being tested
- Evaluation of treatment for liver metastasis
- Keywords
- Liver metastasis, Colorectal carcinoma, Unresectable, Borderline resectable, Initially unresectable
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of treatment for liver metastasisOther
| Study group | Role | What they receive |
|---|---|---|
| Colorectal adenocarcinoma liver metastasis | Unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer Receives: Other: Evaluation of treatment for liver metastasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of post-operative complications
Measured: 1 year
Secondary outcomes (3)
Overall survival after 2 years of follow-up
Measured: 3 years
Progression free survival at 2 years
Measured: 3 years
Number of post-operative complications in the first 50 patients compared to the second 50 patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startMay 2015
- Primary completionJan 2020
- Study completionFeb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasisStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- European Society of Surgical Oncology
- Responsible party
- Sponsor
- Investigators
- Serge Evrard, Prof., Study chair, Institut BergoniéGraeme Poston, Prof., Study chair, Aintree University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218801
- Sponsor's protocol ID
- EORTC-1409-GITCG
- Acronym
- CLIMB
- Status last verified
- May 2022
- First submitted
- 7 Aug 2014
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program
- ClinicalTrials.gov ID
- NCT02218801
- Acronym / sponsor ID
- CLIMB / EORTC-1409-GITCG
- Conditions
- Liver Metastasis, Colorectal Carcinoma
- Keywords
- Liver metastasis, Colorectal carcinoma, Unresectable, Borderline resectable, Initially unresectable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- European Society of Surgical Oncology
- Study start
- May 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Feb 2021 (actual)
- First posted
- 18 Aug 2014 (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 prospective database has two main objectives;
- to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer.
- to establish baseline quality parameters for different surgical strategies for unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM) patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal adenocarcinoma liver metastasis | – | Other: Evaluation of treatment for liver metastasisUnresectable, borderline or initially unresectable liver metastasis from a colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver metastasis of colorectal adenocarcinoma (unresectable, borderline resectable or initially unresectable)
Key inclusion criteria (10 listed)
- With histologically proven colorectal adenocarcinoma with liver metastasis.
- With unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer assessed by a clinician or by a multi-disciplinary tumor board (MDT).
- discussed by a multidisciplinary team before surgery.
- Participants of the MDT must include at least one liver surgeon, one radiologist and one oncologist. They will determine the resectability of the CRLM according to local practice.
- With a possibility of a surgical procedure (resection with or without portal vein embolization, intraoperative local ablative technique or a combined approach) assessed during the MDT.
Key exclusion criteria (2 listed)
- Any psychological, familial, or sociological condition potentially hampering understanding of the research project.
- Any other malignancy other than in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 5 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of treatment for liver metastasis | Other | Colorectal adenocarcinoma liver metastasis |
Primary outcome
Number of post-operative complications
Time frame: 1 year
3 secondary outcomes
Overall survival after 2 years of follow-up
Time frame: 3 years
Progression free survival at 2 years
Time frame: 3 years
Number of post-operative complications in the first 50 patients compared to the second 50 patients
Time frame: 1 year
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 31 May 2022.
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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.
Serge Evrard, Prof. study chair
Institut Bergonié
Graeme Poston, Prof. study chair
Aintree University Hospital
16 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Metastasis and Colorectal Carcinoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 16 sites in 12 countries.
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 10 inclusion and 2 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 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Austria, France, Germany, Netherlands, Belgium and 7 more countries. 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?
Number of post-operative complications (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2022.