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

NCT02218801 | Completed DMC

• 1 other identifier: EORTC-1409-GITCG
• Study Type: observational
• Target: 219
• Locations: 11 countries
• Sites: 15

Brief 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.
• 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

Keywords

Liver metastasis; Colorectal carcinoma; Unresectable; Borderline resectable; Initially unresectable

Outcome Measures

Primary Outcomes (1)

• Number of post-operative complications

  1 year

Secondary Outcomes (3)

• Overall survival after 2 years of follow-up

  3 years

• Progression free survival at 2 years

  3 years

• Number of post-operative complications in the first 50 patients compared to the second 50 patients

  1 year

Study Arms (1)

Colorectal adenocarcinoma liver metastasis

Unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer

Other: Evaluation of treatment for liver metastasis

Interventions

Evaluation of treatment for liver metastasis OTHER

Colorectal adenocarcinoma liver metastasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• European Society of Surgical Oncology: collaborator

Study Sites (16)

Innsbruck Universitaetsklinik

Innsbruck, 6020, Austria

Location

Der Wiener Krankenanstaltenverbund - Krankenanstalt Rudolfstiftung

Vienna, 1030, Austria

Location

University Hosptial Gent

Ghent, 9000, Belgium

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Universitaetsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Klinikum Der J.W. Goethe Universitaet

Frankfurt am Main, 60590, Germany

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

Amsterdam, 1066, Netherlands

Location

Leiden University Medical Centre

Leiden, 2300, Netherlands

Location

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

Location

Hospital De Fuenlabrada

Fuenlabrada, 28942, Spain

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Hôpitaux universitaires de Genève - HUG

Geneva, 1211, Switzerland

Location

Aintree University Hospital NHS Trust

Liverpool, GB L9 7AL, United Kingdom

Location

Biospecimen

Retention: NONE RETAINED

whole blood, plasma, serum and left-over tissue samples from either primary tumor or liver metastasis

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Serge Evrard, Prof.

  Institut Bergonié

  STUDY CHAIR

• Graeme Poston, Prof.

  Aintree University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 18, 2014
• Study Start: May 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2021
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

SE (1); BE (1); DK (1); AU (2); FR (2); IT (1); ES (1); CH (1); NL (2); GB (1); DE (2)