CIRSE Registry for LifePearl Microspheres
Condition: Colorectal Carcinoma; Neoplasm Metastasis
MeSH terms: Neoplasm Metastasis; Colorectal Neoplasms
Study type: Observational [Patient Registry]

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.
    

Intervention name(s): LifePearl Microspheres loaded with Irinotecan
Intervention type(s): Device
Intervention description(s): 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.
Intervention MeSH terms: Irinotecan
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