CIREL

CIRSE REgistry for LifePearl Microspheres

Status: closed

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

Study summary

CIREL is a European-wide, prospective, observational (non-interventional) study collecting data on transarterial chemoembolisation (TACE) using LifePearl Microspheres loaded with irinotecan (LP-irinotecan TACE) in patients with colorectal cancer with liver metastatic disease (CRLM). 80% of CRLM patients have disease that cannot be curatively treated with surgery.

LP-irinotecan TACE works by blocking the blood supply to the liver metastases and by locally eluting the chemotherapeutic drug irinotecan. It is an interventional oncological procedure that has been shown to be a safe and effective option for CRLM patients. CIREL observes the real-life use of the procedure 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 LP-irinotecan TACE.

CIREL has published a paper on the prospective study methodology, as well as a 50-patient interim analysis and has now CIREL has entered the data collection close-out phase. With 152 enrolled patients and up to 4 years of follow-up, CIREL will not only create an important dataset that could greatly impact 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

Documents and links

• Project summary
• https://clinicaltrials.gov/ct2/show/NCT03086096

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