A multicentre, international, observational study on transarterial chemoembolisation in colorectal cancer liver metastases: Design and rationale of CIREL
Philippe L Pereira, Dirk Arnold, Thierry de Baère, Fernando Gomez, Thomas Helmberger, Roberto Iezzi, Geert Maleux, Hans Prenen, Bruno Sangro, Anders Nordlund, Bleranda Zeka, Robert Bauer, Nathalie Kaufmann, Olivier Pellerin, Julien Taieb, Philippe L Pereira, Dirk Arnold, Thierry de Baère, Fernando Gomez, Thomas Helmberger, Roberto Iezzi, Geert Maleux, Hans Prenen, Bruno Sangro, Anders Nordlund, Bleranda Zeka, Robert Bauer, Nathalie Kaufmann, Olivier Pellerin, Julien Taieb
Abstract
Background: About 70-80% of patients with colorectal liver metastases appear as ineligible for a curative treatment approach. Transarterial chemoembolisation (TACE) using irinotecan-eluting beads has emerged as a promising treatment option in cases with irresectable liver metastases. Despite being in clinical practice for years, little is known about the treatment characteristics and outcomes when used as per routine hospital practice.
Methods: Patients with hepatic metastases from colorectal cancer origin, admitted to contributing centres to receive TACE with drug-eluting LifePearl® Microspheres loaded with irinotecan, as part of their standard care, will be consecutively added to the registry. Data will be collected until the end of study, loss to follow-up or death. Primary endpoint is the characterisation of the treatment usage at the selected sites in Europe. Secondary endpoints include outcome parameters, safety and toxicity, as well as quality of life.
Conclusion and aims: This multicentre, international, prospective observational study conducted in European centres plans to collect real-life data. This data will form an evidence-base from which conclusions can be drawn on how to improve patient selection and optimise treatment protocols when treating with TACE using irinotecan-eluting microspheres. Trial registration NCT03086096.
Keywords: TACE; Drug-eluting microspheres; Irinotecan; Chemoembolization.
Conflict of interest statement
Declaration of Competing Interest Prof. Philippe L. Pereira reports personal fees from Terumo. Prof. Thomas Helmberger received speaker honoraria from SIRTEX Medical Europe, Prof. Dirk Arnold received consulting fees and speaker honoraria from TERUMO, Boston Scientific, SIRTEX Medical Europe and Biocompatibles. Prof. Geert Maleux received speaker fees from SIRTEX Medical Europe. Prof. Bruno Sangro has received personal fees from Terumo and BTG, as well as personal fees and a grant from Sirtex Medical. Anders Nordlund, Phd has received personal fees from Cardiovascular and Interventional Radiological Society of Europe. Dr. Ollivier Pellerin has received personal fees from Merit Medical and shareholdings of COGITh-SAS. Prof. Julien Taieb reports receiving honoraria from Merck, Roche, Amgen, Lilly, Sanofi, Samsung, MSD, Servier, Celgene, Pierre Fabre; consulting or advisory Role for Roche, Merck KGaA, Amgen, Lilly, MSD, Servier, Pierre Fabre, Sanofi, Samsung; speakers' Bureau for Servier, Amgen, Roche, Sanofi, Merck, Lilly, Pierre Fabre. Dr. Fernando Gomez, Prof. Hans Prenen, Dr. Roberto Iezzi, Bleranda Zeka, PhD, Robert Bauer, MA and Nathalie Kaufmann, MSc report no conflict of interest.
Copyright © 2020. Published by Elsevier Ltd.
Source: PubMed