Clinical trial NCT03086096: CIRSE Registry for LifePearl Microspheres
Official title: CIRSE Registry for LifePearl Microspheres
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Carcinoma
Neoplasm Metastasis
Lead sponsor: Cardiovascular and Interventional Radiological Society of Europe
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal adenocarcinoma and liver-only or liver-dominant metastatic disease

Brief summary: 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:

1. map the exact indications that the device is being used for and at which stage in treatment it is being applied
2. to assess observed treatment outcomes in terms of safety and effectiveness as well as trying to determine any predictive response factors

Detailed description: 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:

* Immediately (max. 1 week) before the treatment with LP-IRI
* 4-8 weeks after completion of the full treatment with LP-IRI
* 12-16 weeks after the completion of the full treatment with LP-IRI

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.

Eligibility criteria: Inclusion Criteria:

* patients with liver-only or liver-dominant metastatic disease in patients with colorectal adenocarcinoma
* treatment with LifePearl Microspheres
* signed informed consent form
* 18 years or older

Exclusion Criteria:

* withdrawal of informed consent

Primary outcomes:
measure: Number of indications that the device is being used for, as assessed by stage and previous treatment(s)
timeFrame: 2.5 years
Secondary outcomes:
measure: Number of participants with acute and/or chronic adverse events according to CTCAE version 4.03.
timeFrame: 4 years
measure: Time from observation until death due to any cause (or censoring)
timeFrame: 4 years
measure: Time from observation until disease progression or death
timeFrame: 4 years
measure: Time from observation until disease progression in the liver or death
timeFrame: 4 years
measure: Proportion of patients with reduction in tumor burden, as assessed by RECIST (v.1.1)
timeFrame: 4 years
measure: Number of patients with tumour shrinkage at > 20% or >30% at first tumour assessment (4 - 8 wks)
timeFrame: 4 years
measure: Nadir of tumour response over the time of observation
timeFrame: 4 years
measure: Number of patients with secondary resections or ablative treatments following initial treatment with LP-IRI
timeFrame: 4 years
measure: The quality of participants' lives, as assessed by the QLQ-C30 questionnaire (developed by EORTC)
timeFrame: 4 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: CIRSE Cardiovascular and Interventional Radiological Society of Europe
Study officials:
affiliation: Interventional Radiologist at SLK Klinikum Heilbronn GmbH, Germany
name: Philippe Pereira, Prof.
role: STUDY_CHAIR
affiliation: Oncologist at Georges Pompidou European Hospital, Paris, France
name: Julien Taieb, Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.