CIRT-FR - CIRSE Registry for SIR-Spheres Therapy in France
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).
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
- adverse events
- 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
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 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.
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).
|José Ignacio Bilbao (Chairperson)||Clínica Universidad de Navarra/ES|
|Olivier Pellerin (National Coordinator)||Hôpital Européen Georges-Pompidou/FR|
|Dirk Arnold||Asklepios Klinikum Hamburg/DE|
|Roberto Cianni||Azienda Ospedaliera San Camillo Forlanini/IT|
|Samer Ezziddin||Universitätsklinikum des Saarlandes/DE|
|Thomas Helmberger||Klinikum Bogenhausen/DE|
|Frank Kolligs||Helios Klinikum Berlin-Buch/DE|
|Geert Maleux||Universitair Ziekenhuis Leuven/BE|
|Derek Manas||Freeman Hospital/UK|
|Graham Munneke||University College London/UK|
|Bora Peynircioglu||Hacettepe Üniversitesi Tıp Fakültesi/TR|
|Jean Pierre Pelage||CHU de Caen/FR|
|Bruno Sangro||Clínica Universidad de Navarra/ES|
|Niklaus Schäfer||CHUV-Lausanne University Hospital/CH|
|Niels de Jong||CIRSE Office|