CIRT-FR

CIrse Registry for SIR-Spheres Therapy in FRance

Status: closed

Study summary | Endpoints | Methods | Patient enrolment | Steering Committee | Links | Publications

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 objective

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.

Primary endpoint

• First-line SIRT treatment with or without concomitant systemic therapy
• Second or subsequent line SIRT treatment with or without concomitant systemic therapy after previous first-line systemic therapy, including salvage therapy when no other systemic therapies used alone are likely to be efficacious
• SIRT treatment with or without concomitant systemic therapy after previous interventional liver-directed procedures or liver surgery
• Addition of SIRT to systemic therapy (any line) or to any other treatment (e.g. ablation) intended as part of a multimodal curative therapy with any of the following objectives: resectability and/or ablative therapy and/or transplantation
• Treatment with SIRT in patients intolerant of chemotherapy or patients considered not suitable for systemic therapy
• Other

Secondary endpoints

• Safety
• Overall survival / Progression-free survival
• Quality of Life
• Technical considerations
• Diagnosis- and treatment-related considerations

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. Thereafter, follow-up data was collected until July 2022. CIRT-FR closed with 332 patients enrolled.

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

Reimer, P., Vilgrain, V., Arnold, D., et al. Factors Impacting Survival After Transarterial Radioembolization in Patients with Unresectable Intrahepatic Cholangiocarcinoma: A Combined Analysis of the Prospective CIRT Studies. Cardiovasc Intervent Radiol. Online 2023. DOI: 10.1007/s00270-023-03657-x