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CIRSE Registry for LifePearl Microspheres (CIREL)

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ClinicalTrials.gov Identifier: NCT03086096
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Cardiovascular and Interventional Radiological Society of Europe

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 efficacy as well as trying to determine any predictive response factors

Condition or disease Intervention/treatment
Colorectal Carcinoma Neoplasm Metastasis Device: LifePearl Microspheres loaded with Irinotecan

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 500 patients. The registry will stop enrolment three years after the enrolment of the first patient, unless decided differently by the Steering Committee. Patients should be followed up until one year after the enrolment of the last patient.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: CIRSE Registry for LifePearl Microspheres
Actual Study Start Date : April 7, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: LifePearl Microspheres loaded with Irinotecan
    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.


Primary Outcome Measures :
  1. Number of indications that the device is being used for, as assessed by stage and previous treatment(s) [ Time Frame: 3 years ]

    The primary objective is to ultimately categorise observed usages 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)
    • Rescue treatment/end-stage treatment in progressive patients pre-treated with systemic therapy, with or without concomitant systemic therapy


Secondary Outcome Measures :
  1. Number of participants with acute and/or chronic adverse events according to CTCAE version 4.03. [ Time Frame: 3 years ]
    Safety and Tolerability will be monitored before, during and/or after treatment with LP-IRI.

  2. Time from observation until death due to any cause (or censoring) [ Time Frame: 3 years ]
    Overall survival

  3. Time from observation until disease progression or death [ Time Frame: 3 years ]
    Progression-free survival (PFS) will be assessed by the investigator and central CT/MRI image analysis.

  4. Time from observation until disease progression in the liver or death [ Time Frame: 3 years ]
    Hepatic progression-free survival (liver-specific PFS) will be assessed by the investigator and central CT/MRI image analysis.

  5. Proportion of patients with reduction in tumor burden, as assessed by RECIST (v.1.1) [ Time Frame: 3 years ]
    Objective Tumour Response Rate will be assessed by the investigator and central CT/MRI image analysis.

  6. Number of patients with tumour shrinkage of at least 20% at first tumour assessment (4 - 8 wks) [ Time Frame: 3 years ]
    Assessment of early tumour shrinkage serves as an early-on-treatment predictor of treatment efficacy.

  7. Nadir of tumour response over the time of observation [ Time Frame: 3 years ]
    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.

  8. Number of patients with secondary resections or ablative treatments following initial treatment with LP-IRI [ Time Frame: 3 years ]
    Secondary resection/ablation

  9. The quality of participants' lives, as assessed by the QLQ-C30 questionnaire (developed by EORTC) [ Time Frame: 3 years ]

    Quality of Life questionnaires will be filled out:

    • Baseline: maximum 1 week before the first LP-IRI treatment
    • 2nd: 4-8 weeks after the whole LP-IRI treatment is completed
    • 3rd: 12-16 weeks after the whole LP-IRI treatment is completed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with colorectal adenocarcinoma and liver-only or liver-dominant metastatic disease
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086096


Contacts
Contact: Robert Bauer +43 1 904 2003 ext 37 bauer@cirse.org
Contact: Nathalie Kaufmann +43 1 904 2003 ext 53 kaufmann@cirse.org

Locations
Austria
CIRSE Cardiovascular and Interventional Radiological Society of Europe Recruiting
Vienna, Austria, 1010
Contact: Robert Bauer, MA    +43 1 904 2003 ext 37    bauer@cirse.org   
Contact: Nathalie Kaufmann, MSc    +43 1 904 2003 ext 53    kaufmann@cirse.org   
Sponsors and Collaborators
Cardiovascular and Interventional Radiological Society of Europe
Investigators
Study Chair: Philippe Pereira, Prof. Radiology, Minimally Invasive Therapies and Nuclear Medicine at SLK Klinikum Heilbronn, Germany
Study Chair: Julien Taieb, Prof. GI Oncology Department Georges Pompidou European Hospital, Paris, France

Responsible Party: Cardiovascular and Interventional Radiological Society of Europe
ClinicalTrials.gov Identifier: NCT03086096     History of Changes
Other Study ID Numbers: 2
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action