A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program (CLIMB)

May 27, 2022 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

219

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Innsbruck Universitaetsklinik
      • Vienna, Austria, 1030
        • Der Wiener Krankenanstaltenverbund - Krankenanstalt Rudolfstiftung
  • Belgium
      • Gent, Belgium, 9000
        • University Hosptial Gent
  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital
  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Lyon, France, 69008
        • Centre Leon Berard
  • Germany
      • Dresden, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus
      • Frankfurt Am Main, Germany, 60590
        • Klinikum der J.W. Goethe Universitaet
  • Italy
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia
  • Netherlands
      • Amsterdam, Netherlands, 1066
        • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
      • Leiden, Netherlands, 2300
        • Leiden University Medical Centre
  • Serbia
      • Sremska Kamenica, Serbia, 21204
        • Oncology Institute of Vojvodina
  • Spain
      • Fuenlabrada, Spain, 28942
        • Hospital De Fuenlabrada
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital
  • Switzerland
      • Geneve, Switzerland, 1211
        • Hopitaux Universitaires de Geneve - HUG
  • United Kingdom
      • Liverpool, United Kingdom, GB L9 7AL
        • Aintree University Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with liver metastasis of colorectal adenocarcinoma (unresectable, borderline resectable or initially unresectable)

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Colorectal adenocarcinoma liver metastasis
Unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer
Other: Evaluation of treatment for liver metastasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of post-operative complications
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival after 2 years of follow-up
Time Frame: 3 years
3 years
Progression free survival at 2 years
Time Frame: 3 years
3 years
Number of post-operative complications in the first 50 patients compared to the second 50 patients
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

European Society of Surgical Oncology

Investigators

  • Study Chair: Serge Evrard, Prof., Institut Bergonie
  • Study Chair: Graeme Poston, Prof., Aintree University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 15, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-1409-GITCG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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