Cardiovascular and Interventional Radiological Society of Europe
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ResearchCIREL

CIRSE Registry for LifePearl Microspheres CIREL

Status: recruiting

CIREL will greatly contribute to the collection of scientific knowledge and clinical data in one of interventional radiology’s most dynamic and promising fields and help us understand better what could be the potential indications to treat patients with TACE.

Study summary

CIREL is a European-wide, prospective, observational (non-interventional) study that gathers data on transarterial chemoembolisation (TACE) using LifePearl Microspheres loaded with irinotecan (LP-IRI) in patients with colorectal cancer (CRC) with liver metastatic disease. The registry observes the real-life use of the device in the context of the patients’ entire cancer treatment and collects extensive data regarding safety and toxicity, efficacy and treatment-related quality of life. The collection of real-life data is intended to form an evidence-base from which conclusions can be drawn on how to improve patient selection and optimise treatment protocols to ultimately improve the therapy outcome of patients treated with TACE performed with LifePearl Microspheres

CIREL spans the continent and aims to enrol 500 patients over an initial period of three years and with a minimum follow-up of 12 months is projected to end in February 2022. The Steering Committee agrees that this registry will not only create an important dataset that could greatly impact patient selection in TACE, but if successful, may stimulate further research into interventional oncological procedures.

Endpoints

The primary objective of CIREL is to categorise observed usages of LP-IRI as one of the following:

  • LifePearl as a first-line treatment
  • LifePearl as a consolidation or closing treatment with or without systemic therapy
  • Intensification of treatment with concomitant systemic therapy (objective: resectability and/or ablative therapy)
  • Salvage treatment in progressive patients pre-treated with systemic therapy, with or without concomitant systemic therapy
  • Other

The secondary objectives of CIREL are the following:

  • Adverse events and toxicity
  • Overall survival (OS)
  • Progression-free survival (PFS)
  • Hepatic progression-free survival
  • Objective Response Rate
  • Early tumour shrinkage at ≥20% or ≥30% at first tumour assessment
  • Deepness of response
  • Secondary resection or ablation
  • Quality of Life

Steering Committee

The CIREL Steering Committee
NameHospital
Philippe Pereira (Co-Chairperson)SLK Heilbronn/DE
Julien Taieb (Co-Chairperson)Hôpital Georges-Pompidou/FR
Dirk ArnoldAsklepios Klinik Altona /DE
Patrick ChevallierChu de Nice/FR
Thierry de BaèreInstitut Gustave Roussy/FR
Raúl García MarcosHospital Universitari i Politècnic La Fe/ES
Fernando GomezHospital Clínic de Barcelona/ES
Thomas HelmbergerStädtisches Klinikum München/DE
Roberto IezziPoliclinico Universitario Agostino Gemelli/IT
Geert MaleuxUZ Leuven/BE
Hassan MalikAintree University Hospital/UK
Olivier PellerinHôpital Georges-Pompidou/FR
Simon PernotHôpital Georges-Pompidou/FR
Hans PrenenUZ Antwerp/BE
Bruno SangroClinica Universidad de Navarra/ES