Clinical trial NCT02218801: A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program
Official title: A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Metastasis
Colorectal Carcinoma
Keywords: Liver metastasis
Colorectal carcinoma
Unresectable
Borderline resectable
Initially unresectable
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: European Society of Surgical Oncology
First posted: 2014-08-18
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver metastasis of colorectal adenocarcinoma (unresectable, borderline resectable or initially unresectable)

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of post-operative complications
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival after 2 years of follow-up
timeFrame: 3 years
measure: Progression free survival at 2 years
timeFrame: 3 years
measure: Number of post-operative complications in the first 50 patients compared to the second 50 patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck Universitaetsklinik
city: Vienna
country: Austria
facility: Der Wiener Krankenanstaltenverbund - Krankenanstalt Rudolfstiftung
city: Gent
country: Belgium
facility: University Hosptial Gent
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Bordeaux
country: France
facility: Institut Bergonie
city: Lyon
country: France
facility: Centre Leon Berard
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Frankfurt Am Main
country: Germany
facility: Klinikum Der J.W. Goethe Universitaet
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Amsterdam
country: Netherlands
facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
city: Sremska Kamenica
country: Serbia
facility: Oncology Institute of Vojvodina
city: Fuenlabrada
country: Spain
facility: Hospital De Fuenlabrada
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Geneve
country: Switzerland
facility: Hôpitaux universitaires de Genève - HUG
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital NHS Trust
Study officials:
affiliation: Institut Bergonié
name: Serge Evrard, Prof.
role: STUDY_CHAIR
affiliation: Aintree University Hospital
name: Graeme Poston, Prof.
role: STUDY_CHAIR
References: