CIrse REgistry for LifePearl Microspheres
Status: closed
CIREL
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.
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.
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-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
- 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
| Name | Hospital | ||
|---|---|---|---|
| Philippe Pereira (Co-Chairperson) | SLK Heilbronn/DE | ||
| Julien Taieb (Co-Chairperson) | Hôpital Européen Georges-Pompidou/FR | ||
| Dirk Arnold | Asklepios Tumorzentrum Hamburg/DE | ||
| Patrick Chevallier | Chu de Nice/FR | ||
| Thierry de Baère | Institut Gustave Roussy/FR | ||
| Raúl García Marcos | Hospital Universitari i Politècnic La Fe/ES | ||
| Fernando Gomez | Hospital Clínic de Barcelona/ES | ||
| Thomas Helmberger | Städtisches Klinikum München/DE | ||
| Roberto Iezzi | Policlinico Universitario Agostino Gemelli/IT | ||
| Geert Maleux | UZ Leuven/BE | ||
| Hassan Malik | Aintree University Hospital/GB | ||
| Olivier Pellerin | Hôpital Européen Georges-Pompidou/FR | ||
| Simon Pernot | Hôpital Européen Georges-Pompidou/FR | ||
| Hans Prenen | UZ Antwerp/BE | ||
| Bruno Sangro | Clinica Universidad de Navarra/ES | ||
Documents and links
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, P.L., Iezzi, R., Manfredi R. et al. 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 (2020). DOI: 10.1007/s00270-020-02646-8, PMID 32974773