A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program
NCT ID: NCT02218801
Last Updated: 2022-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
219 participants
OBSERVATIONAL
2015-05-31
2021-02-28
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Colorectal adenocarcinoma liver metastasis
Unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer
Evaluation of treatment for liver metastasis
Interventions
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Evaluation of treatment for liver metastasis
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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European Society of Surgical Oncology
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Serge Evrard, Prof.
Role: STUDY_CHAIR
Institut Bergonié
Graeme Poston, Prof.
Role: STUDY_CHAIR
Aintree University Hospital
Locations
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Innsbruck Universitaetsklinik
Innsbruck, , Austria
Der Wiener Krankenanstaltenverbund - Krankenanstalt Rudolfstiftung
Vienna, , Austria
University Hosptial Gent
Ghent, , Belgium
Aarhus University Hospital
Aarhus, , Denmark
Institut Bergonie
Bordeaux, , France
Centre Leon Berard
Lyon, , France
Universitaetsklinikum Carl Gustav Carus
Dresden, , Germany
Klinikum Der J.W. Goethe Universitaet
Frankfurt am Main, , Germany
Istituto Europeo di Oncologia
Milan, , Italy
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam, , Netherlands
Leiden University Medical Centre
Leiden, , Netherlands
Oncology Institute of Vojvodina
Kamenitz, , Serbia
Hospital De Fuenlabrada
Fuenlabrada, , Spain
Karolinska University Hospital
Stockholm, , Sweden
Hôpitaux universitaires de Genève - HUG
Geneva, , Switzerland
Aintree University Hospital NHS Trust
Liverpool, , United Kingdom
Countries
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Other Identifiers
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EORTC-1409-GITCG
Identifier Type: -
Identifier Source: org_study_id
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