Status:
COMPLETED
A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Collaborating Sponsors:
European Society of Surgical Oncology
Conditions:
Liver Metastasis
Colorectal Carcinoma
Eligibility:
All Genders
18+ years
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 init...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT02218801
Start Date
May 1 2015
End Date
February 1 2021
Last Update
May 31 2022
Active Locations (16)
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1
Innsbruck Universitaetsklinik
Innsbruck, Austria, 6020
2
Der Wiener Krankenanstaltenverbund - Krankenanstalt Rudolfstiftung
Vienna, Austria, 1030
3
University Hosptial Gent
Ghent, Belgium, 9000
4
Aarhus University Hospital
Aarhus, Denmark, 8000