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Cardiovascular and Interventional Radiological Society of Europe
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ResearchCIRT-FR

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

Status: in follow-up

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
  • treatment complications
  • laboratory assessments

Effectiveness

  • overall survival (OS)
  • progression free survival (PFS)
  • liver specific PFS

Quality of life

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

Technical considerations

  • patient related characteristics
  • treatment related characteristics
  • treatment administration
  • procedure-related outcomes

Diagnosis- and treatment-related considerations

  • type of liver cancer
  • intention of the treatment
  • prior hepatic procedures
  • associated systemic therapy
  • post-SIRT hepatic procedures

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 in August 2017 and ended in July 2020. Follow-up inclusion will be done until July 2022. A full report will be submitted to HAS by August 2021.

Patient enrolment

Patient inclusion started in August 2017 and ended in July 2020. CIRT-FR aims to enrol all patients treated with SIR-Spheres microspheres during this period. Follow-up information will be collected until July 2022.

Steering Committee

CIRT-FR is governed by a multidisciplinary Steering Committee, 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. Valérie Vilgrain (Hôpital Beaujon, FR) together with Prof. Thomas Helmberger (Städtisches Klinikum München – Klinikum Bogenhausen, DE), and the National Coordinator for the study is Dr. Olivier Pellerin (Hôpital George Pompidou, Paris, FR).

NameHospital
Valérie Vilgrain (Chairperson)Hôpital Beaujon/FR
Thomas Helmberger (Chairperson)Klinikum Bogenhausen/DE
Olivier Pellerin (National Coordinator)Hôpital Européen Georges-Pompidou/FR
Dirk ArnoldAsklepios Klinikum Hamburg/DE
Geert MaleuxUniversitair Ziekenhuis Leuven/BE
Bora PeynirciogluHacettepe Üniversitesi Tıp Fakültesi/TR
Bruno SangroClínica Universidad de Navarra/ES
Niklaus SchäferCHUV-Lausanne University Hospital/CH
Maxime RonotHôpital Beaujon/FR
Romanic LoffroyCHU de Dijon/FR
Nathalie KaufmannCIRSE Office