- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03086096
CIRSE Registry for LifePearl Microspheres (CIREL)
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:
- map the exact indications that the device is being used for and at which stage in treatment it is being applied
- to assess observed treatment outcomes in terms of safety and effectiveness as well as trying to determine any predictive response factors
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1010
- CIRSE Cardiovascular and Interventional Radiological Society of Europe
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of indications that the device is being used for, as assessed by stage and previous treatment(s)
Time Frame: 2.5 years
|
The primary objective is to ultimately categorise observed usages as one of the following:
|
2.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with acute and/or chronic adverse events according to CTCAE version 4.03.
Time Frame: 4 years
|
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)
Time Frame: 4 years
|
Overall survival
|
4 years
|
Time from observation until disease progression or death
Time Frame: 4 years
|
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
Time Frame: 4 years
|
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)
Time Frame: 4 years
|
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)
Time Frame: 4 years
|
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
Time Frame: 4 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.
|
4 years
|
Number of patients with secondary resections or ablative treatments following initial treatment with LP-IRI
Time Frame: 4 years
|
Secondary resection/ablation
|
4 years
|
The quality of participants' lives, as assessed by the QLQ-C30 questionnaire (developed by EORTC)
Time Frame: 4 years
|
Quality of Life questionnaires will be filled out:
|
4 years
|
Collaborators and Investigators
Investigators
- Study Chair: Philippe Pereira, Prof., Interventional Radiologist at SLK Klinikum Heilbronn GmbH, Germany
- Study Chair: Julien Taieb, Prof., Oncologist at Georges Pompidou European Hospital, Paris, France
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Colorectal Neoplasms
- Neoplasm Metastasis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Irinotecan
Other Study ID Numbers
- 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasm Metastasis
-
Betta Pharmaceuticals Co., Ltd.Recruiting
-
BayerCompleted
-
BayerCompletedNeoplasm Metastasis / Bone and BonesBelgium, Spain, Taiwan, United States, Japan, Russian Federation, Canada, Finland, Korea, Republic of, Singapore, Australia, Germany, Israel, United Kingdom, Italy, France, Poland, Brazil, Czechia, Norway, Sweden, Hong Kong
-
National Cancer Institute (NCI)TerminatedCancer | Neoplasm Metastasis | Metastasis | Neoplasm | Radiation OncologyUnited States
-
MedtronicNeuroCompletedMetastasis Spine | Metastasis to BoneUnited States, Luxembourg, Germany, France, Canada
-
Cho Ray HospitalUniversity of Medicine and Pharmacy at Ho Chi Minh CityRecruitingSynchronous Neoplasm | Liver Metastasis Colon CancerVietnam
-
Li MinRecruiting
-
Da FuGanzhou City People's HospitalRecruiting
-
University of Mississippi Medical CenterCompletedMetastasisUnited States
-
Assiut UniversityNot yet recruiting
Clinical Trials on LifePearl Microspheres loaded with Irinotecan
-
Terumo Europe N.V.Universitaire Ziekenhuizen KU Leuven; Federation Francophone de Cancerologie...Completed
-
Cardiovascular and Interventional Radiological...Completed
-
Terumo Europe N.V.CompletedHepatocellular CarcinomaBelgium, France
-
Cardiovascular and Interventional Radiological...Completed
-
Terumo Europe N.V.Federation Francophone de Cancerologie Digestive; Fundacion Clinic per a la...Completed
-
Singapore General HospitalSinghealth FoundationCompletedColorectal Cancer MetastaticSingapore
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingCarcinoma, HepatocellularItaly
-
Taipei Physical Education CollegeCompleted
-
Methodist Health SystemRecruitingHepatocellular CarcinomaUnited States
-
Zhongda HospitalNot yet recruitingColorectal Cancer Liver Metastasis