Cardiovascular and Interventional Radiological Society of Europe
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ResearchCIRT-FR

CIRT-FR - CIRSE Registry for SIR-Spheres Therapy in France

Status: enrolling

Registries are a very important part of our work in interventional radiology, because when we demonstrate what we do in daily practice and provide good scientific support, the information we deliver is very important for establishing guidelines or determining how we engage with other medical or surgical specialities.

Study summary

Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal invasive, endovascular treatment for primary and secondary liver tumours. In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de Santé [HAS]). In order to evaluate the reimbursement after five years, all patients treated with SIR-Spheres will be entered into a registry that collects data on the real-life clinical application of SIRT and reports to the national authorities.

Due to their expertise and experience with the European-wide observational study CIRT (CIRSE Registry for SIR-Spheres Therapy), the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), was offered to independently initiate the CIRSE Registry for SIR-Spheres Therapy in France (CIRT-FR).

Endpoints

Primary endpoint

The primary objective is to observe the real-life clinical application of SIRT with SIR-Spheres Y-90 resin microspheres and the impact of the treatment in clinical practice. Patients will be classified according to the following categories:

  • Type of liver cancer
  • Intention of treatment
  • Prior hepatic procedures
  • Associated systemic therapy
  • Post-SIRT hepatic procedures

Secondary endpoints

Safety

  • adverse events

Effectiveness

  • overall Survival (OS)
  • progression free survival (PFS) by investigator
  • liver specific PFS by investigator
  • imaging response

Quality of life

  • measured with EORTC’s QLQ-C30 with HCC module

Methods

Data will be collected prospectively from medical centres in France via an electronic data capture (EDC) system. All hospitals that are using SIR-Spheres or planning on using SIR-Spheres within 1 month will be invited to participate. Patient inclusion started on 1 August 2017 and is planned to continue until 1 August 2019. Follow-up inclusion will be done until May 2021. A full report will be submitted to HAS by February 2022.

Patient enrollment

Patient inclusion started on 1 August 2017 and is open until 31 July 2019. CIRT-FR aims to enrol all patients treated with SIR-Spheres microspheres during this period. Follow-up information will be collected until May 2021.

Steering Committee

CIRT-FR is governed by the same multidisciplinary Steering Committee as CIRT, which is composed of leading experts from the fields of interventional radiology, oncology, surgery, hepatology, internal medicine, and nuclear medicine. The Committee is chaired by Prof. José Ignacio Bilbao (Clínica Universidad de Navarra, Pamplona, ES) and the National Coordinator for the study is Dr. Olivier Pellerin (Hôpital George Pompidou, Paris, FR).

The CIRT-FR Steering Committee
NameHospital
José Ignacio Bilbao (Chairperson)Clínica Universidad de Navarra/ES
Olivier Pellerin (National Coordinator)Hôpital Européen Georges-Pompidou/FR
Dirk ArnoldAsklepios Klinikum Hamburg/DE
Roberto CianniAzienda Ospedaliera San Camillo Forlanini/IT
Samer EzziddinUniversitätsklinikum des Saarlandes/DE
Thomas HelmbergerKlinikum Bogenhausen/DE
Frank KolligsHelios Klinikum Berlin-Buch/DE
Geert MaleuxUniversitair Ziekenhuis Leuven/BE
Derek ManasFreeman Hospital/UK
Graham MunnekeUniversity College London/UK
Bora PeynirciogluHacettepe Üniversitesi Tıp Fakültesi/TR
Jean Pierre PelageCHU de Caen/FR
Bruno SangroClínica Universidad de Navarra/ES
Niklaus SchäferCHUV-Lausanne University Hospital/CH
Niels de JongCIRSE Office