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

Completed

• Conditions: Liver Metastasis; Colorectal Carcinoma

• Registration Number: NCT02218801
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-18
• Study Start: 2015-05
• Primary Completion: 2020-01
• Study Completion: 2021-02
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of post-operative complications	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (16)

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

Der Wiener Krankenanstaltenverbund - Krankenanstalt Rudolfstiftung; 🇦🇹 Vienna, Austria

University Hosptial Gent; 🇧🇪 Gent, 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; 🇮🇹 Milano, Italy

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis; 🇳🇱 Amsterdam, Netherlands

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