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The application of transarterial chemoembolisation (TACE) using LifePearl Microspheres loaded with Irinotecan in liver-only or liver-dominant metastatic disease in patients with colorectal adenocarcinoma will be observed. The registry has the following objectives:
CIREL will capture a broad spectrum of real clinical data on the delivery of transcatheter arterial chemoembolisation (TACE) using LifePearl Microspheres loaded with Irinotecan (LP-IRI) and the observed clinical outcomes. The aim of doing so is to improve our understanding of how LifePearl microspheres are administered as part of the standard treatment of colorectal adenocarcinoma with liver metastases in Europe. Ultimately, the collection of real-life data is intended to provide an evidence-base from which conclusions can be drawn on how to optimise treatment protocols and consequently the therapy outcome of TACE performed with LifePearl Microspheres.
The CIREL registry is a prospective multicentre observational (non-interventional) study. In order to meet the objective of collecting real-life data, all subjects receiving TACE with LifePearl Microspheres loaded with Irinotecan and fulfilling the inclusion criteria in all participating centres will be asked to participate. Patients are only asked to participate in the registry when they are treated with LifePearl Microspheres loaded with Irinotecan as part of the treatment determined by the treating clinician. In no way, will participation in the registry influence the way in which the patient is treated according to the treating clinician, or will it influence the quality of the treatment.
In order to measure changes in the quality of life of enrolled patients at different moments in time before and after treatment with LifePearl microspheres, CIREL will incorporate the EORTC QLQ-C30 questionnaire. The quality of life questionnaire is suggested to be offered to the patient at the following three points in time:
Filling out the quality-of-life questionnaire is entirely voluntary for the patient. The patient will be offered to fill out the questionnaire in his/her mother tongue. The patient will have the choice to fill in the questionnaire either in hard copy or online via the electronic data capture system.
The CIREL registry will include central image analysis performed by the Fédération Francophone de Cancérologie Digestive (FFCD). The aim of the analyis is to detect possible associations between RECIST (v1.1) criteria and observed outcomes, reduce bias by providing a second reading and raise data quality.
The registry aims at enrolling up to 150 patients. The registry will stop enrolment two and a half years after the enrolment of the first patient, unless decided differently by the Steering Committee. Patients should be followed up until 65% of active patients are deceased and for at least 12 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LifePearl Microspheres loaded with Irinotecan | Device | LifePearl Microspheres are embolisation microspheres for transcatheter chemoembolisation (TACE), that can be loaded with chemotherapeutic agents. In this registry, LifePearl Microspheres will be loaded with Irinotecan. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of indications that the device is being used for, as assessed by stage and previous treatment(s) | The primary objective is to ultimately categorise observed usages as one of the following:
| 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with acute and/or chronic adverse events according to CTCAE version 4.03. | Safety and Tolerability will be monitored during and after treatment with LP-IRI. | 4 years |
| Time from observation until death due to any cause (or censoring) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with colorectal adenocarcinoma and liver-only or liver-dominant metastatic disease
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Pereira, Prof. | Interventional Radiologist at SLK Klinikum Heilbronn GmbH, Germany | Study Chair |
| Julien Taieb, Prof. | Oncologist at Georges Pompidou European Hospital, Paris, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIRSE Cardiovascular and Interventional Radiological Society of Europe | Vienna | State of Vienna | 1010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32974773 | Result | Pereira PL, Iezzi R, Manfredi R, Carchesio F, Bansaghi Z, Brountzos E, Spiliopoulos S, Echevarria-Uraga JJ, Goncalves B, Inchingolo R, Nardella M, Pellerin O, Sousa M, Arnold D, de Baere 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. Epub 2020 Sep 24. | |
| 32620520 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Overall survival |
| 4 years |
| Time from observation until disease progression or death | Progression-free survival (PFS) will be assessed by the investigator and central CT/MRI image analysis. | 4 years |
| Time from observation until disease progression in the liver or death | Hepatic progression-free survival (liver-specific PFS) will be assessed by the investigator and central CT/MRI image analysis. | 4 years |
| Proportion of patients with reduction in tumor burden, as assessed by RECIST (v.1.1) | Objective Tumour Response Rate will be assessed by the investigator and central CT/MRI image analysis. | 4 years |
| Number of patients with tumour shrinkage at > 20% or >30% at first tumour assessment (4 - 8 wks) | Assessment of early tumour shrinkage serves as an early-on-treatment predictor of treatment efficacy. | 4 years |
| Nadir of tumour response over the time of observation | Deepness of response (DpR) serves as a continuous measure, which defines the nadir of tumour response and serves as an early-on-treatment predictor of treatment efficacy. | 4 years |
| Number of patients with secondary resections or ablative treatments following initial treatment with LP-IRI | Secondary resection/ablation | 4 years |
| The quality of participants' lives, as assessed by the QLQ-C30 questionnaire (developed by EORTC) | Quality of Life questionnaires will be filled out:
| 4 years |
| Result |
| Pereira PL, Arnold D, de Baere 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. Epub 2020 Jun 30. |
| 36294499 | Result | 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. |
| 39954388 | Result | Arnold D, Pereira PL, Iezzi R, Gjoreski A, Spiliopoulos S, Helmberger T, Gomez FM, de Baere T, Pellerin O, Maleux G, Prenen H, Sangro B, Zeka B, Kaufmann NC, Taieb J. Transarterial chemoembolisation with irinotecan (irinotecan-TACE) as salvage or post-inductive therapy for colorectal cancer liver metastases: effectiveness results from the CIREL study. ESMO Open. 2025 Mar;10(3):104292. doi: 10.1016/j.esmoop.2025.104292. Epub 2025 Feb 15. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |