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ProjectsClinical studiesCIREL

CIREL

CIRSE REgistry for LifePearl Microspheres

Status: closed

Study summary | Endpoints | Steering Committee | Documents and links | Publications

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.
Philippe Pereira | Coordinating Investigator
CIREL was designed to provide real-life data for irinotecan-TACE for CRLM patients, a previously underexplored therapy with insufficient level of evidence. The collected data will increase the knowledge base for treating salvage therapy patients with limited treatment options and explore the potential for the use in earlier stages of the cancer continuum care.
Julien Taieb | Coordinating Investigator

Study summary

CIREL is a European-wide, prospective, observational (non-interventional) study that gathered data on transarterial chemoembolization (TACE) using LifePearl Microspheres loaded with irinotecan (LP-IRI) in patients with colorectal cancer (CRC) with liver metastases (CRLM). The registry observed the real-life use of the device in the context of the patients’ entire cancer treatment and collected extensive data regarding safety and toxicity, effectiveness and health-related quality of life. The collection of real-life data was intended to form an evidence-base from which conclusions could 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 spanned the continent and enrolled 152 patients over a period of 30 months. Minimum follow-up was 12 months and ended in April, 2022. The Steering Committee agrees that this registry has not only created an important dataset that could greatly impact CRLM patient selection in TACE, but also may stimulate further research into interventional oncological procedures.

Endpoints

The primary objective of CIREL is to categorise observed usages of LP-irinotecan TACE 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 or without concomitant systemic therapy
  • Salvage treatment in progressive patients pre-treated with systemic therapy, with or without concomitant systemic therapy
  • Combination treatment with ablation with curative intent
  • 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 Européen Georges-Pompidou/FR
Dirk ArnoldAsklepios Tumorzentrum Hamburg/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/GB
Olivier PellerinHôpital Européen Georges-Pompidou/FR
Simon PernotHôpital Européen Georges-Pompidou/FR
Hans PrenenUZ Antwerp/BE
Bruno SangroClinica Universidad de Navarra/ES

Publications

Helmberger T, Lucatelli P, Pereira PL, Gjoreski A, Jovanoska I, Bansaghi Z, Spiliopoulos S, Carchesio F, Arnold D, Baierl A, Zeka B, Kaufmann NC, Taieb J, Iezzi R. Safety, Feasibility and Technical Considerations from a Prospective, Observational Study-CIREL: Irinotecan-TACE for CRLM in 152 Patients. J Clin Med. 2022 Oct 19;11(20):6178. DOI: 10.3390/jcm11206178. PMID: 36294499

Pereira PL, Arnold D, de Baère T, Gomez F, Helmberger T, Iezzi R, Maleux G, Prenen H, Sangro B, Nordlund A, Zeka B, Bauer R, Kaufmann N, Pellerin O, Taieb J. A multicentre, international, observational study on transarterial chemoembolisation in colorectal cancer liver metastases: Design and rationale of CIREL. Dig Liver Dis. 2020 Aug;52(8):857-861. DOI: 10.1016/j.dld.2020.05.051, PMID: 32620520

Pereira PL, Iezzi R, Manfredi R, Carchesio F, Bánsághi Z, Brountzos E, Spiliopoulos S, Echevarria-Uraga JJ, Gonçalves B, Inchingolo R, Nardella M, Pellerin O, Sousa M, Arnold D, de Baère T, Gomez F, Helmberger T, Maleux G, Prenen H, Sangro B, Zeka B, Kaufmann N, Taieb J. The CIREL Cohort: A Prospective Controlled Registry Studying the Real-Life Use of Irinotecan-Loaded Chemoembolisation in Colorectal Cancer Liver Metastases: Interim Analysis. Cardiovasc Intervent Radiol. 2021 Jan;44(1):50-62. DOI: 10.1007/s00270-020-02646-8. PMID: 32974773