CIrse Registry for SIR-Spheres Therapy in FRance
Status: closed
CIRT-FR
Study summary
Selective Internal Radiation Therapy (SIRT), also known as radioembolization, is a minimally 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 had to be entered into a registry collecting data on the real-life clinical application of SIRT, which was reported 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 was collected prospectively from medical centres in France via an electronic data capture (EDC) system. All hospitals that were using SIR-Spheres or planning on using SIR-Spheres within 1 month at the time of enrolment were invited to participate. Patient inclusion started in August 2017 and ended in July 2020. Follow-up inclusion was completed in July 2022. A full report was submitted to HAS in 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).
| Name | Hospital | ||
|---|---|---|---|
| Valérie Vilgrain (Chairperson) | Hôpital Beaujon/FR | ||
| Thomas Helmberger (Chairperson) | Klinikum Bogenhausen/DE | ||
| Olivier Pellerin (National Coordinator) | Hôpital Européen Georges-Pompidou/FR | ||
| Dirk Arnold | Asklepios Klinikum Hamburg/DE | ||
| Bora Peynircioglu | Hacettepe Üniversitesi Tıp Fakültesi/TR | ||
| Bruno Sangro | Clínica Universidad de Navarra/ES | ||
| Geert Maleux | Universitair Ziekenhuis Leuven/BE | ||
| Jean-Pierre Pelage | CHU de Caen/FR | ||
| Maxime Ronot | Hôpital Beaujon/FR | ||
| Niklaus Schäfer | CHUV-Lausanne University Hospital/CH | ||
| Romanic Loffroy | CHU de Dijon/FR | ||
Publications
Loffroy, R., Ronot, M., Greget, M. et al. Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France. Cardiovasc Intervent Radiol (2020). DOI: 10.007/s00270-020-02643-x, PMID: 32975600