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

Colorectal Carcinoma Clinical Trial

— CLIMB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218801
• Other study ID #: EORTC-1409-GITCG
• Status: Completed
• Start date: May 2015
• Est. completion date: February 2021

Study information

• Verified date: May 2022
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: February 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms
• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Other:
• Evaluation of treatment for liver metastasis

Locations

Country	Name	City	State
Austria	Innsbruck Universitaetsklinik	Innsbruck
Austria	Der Wiener Krankenanstaltenverbund - Krankenanstalt Rudolfstiftung	Vienna
Belgium	University Hosptial Gent	Gent
Denmark	Aarhus University Hospital	Aarhus
France	Institut Bergonie	Bordeaux
France	Centre Leon Berard	Lyon
Germany	Universitaetsklinikum Carl Gustav Carus	Dresden
Germany	Klinikum Der J.W. Goethe Universitaet	Frankfurt Am Main
Italy	Istituto Europeo di Oncologia	Milano
Netherlands	The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis	Amsterdam
Netherlands	Leiden University Medical Centre	Leiden
Serbia	Oncology Institute of Vojvodina	Sremska Kamenica
Spain	Hospital De Fuenlabrada	Fuenlabrada
Sweden	Karolinska University Hospital	Stockholm
Switzerland	Hôpitaux universitaires de Genève - HUG	Geneve
United Kingdom	Aintree University Hospital NHS Trust	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC	European Society of Surgical Oncology

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Italy,  Netherlands,  Serbia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of post-operative complications		1 year
Secondary	Overall survival after 2 years of follow-up		3 years
Secondary	Progression free survival at 2 years		3 years
Secondary	Number of post-operative complications in the first 50 patients compared to the second 50 patients		1 year