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The CIRSE Registry for SIR-Spheres Therapy in France (CIRT-FR)

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).

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, Spain) and the National Coordinator for the study is Dr. Olivier Pellerin (Hôpital George Pompidou, Paris, France).

 

Primary endpoints
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. This will be categorised as one of the following:

  1. First-line SIRT treatment with or without concomitant systemic therapy
  2. 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
  3. SIRT treatment with or without concomitant systemic therapy after previous interventional liver-directed procedures or liver surgery
  4. 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
  5. Treatment with SIRT in patients intolerant of chemotherapy or patients considered not suitable for systemic therapy
  6. Other

 

Secondary endpoints
The secondary endpoints of the study assess the observed treatment outcomes of SIRT with SIR-Spheres Y-90 resin microspheres in terms of safety, effectiveness, surgery–ablation and quality of life. The following table indicates the variables to measure the secondary endpoints.

Safety Adverse events
Effectiveness • Overall Survival (OS)
• Progression free survival (PFS) by investigator
• liver specific PFS by investigator
Surgery-Ablation To document the safety and effectiveness of SIRT and subsequent surgical or interventional procedures in patients with:
a. Previous surgery or ablation or other liver-directed therapy
b. Patients proceeding to have surgery or ablation post-SIRT
Quality of Life • Measured with EORTC’s QLQ-C30 with HCC Module
• Questionnaire will be offered to patient before treatment, within one week after treatment and at every follow-up

 

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.

To measure the impact of the treatment on patients’ quality of life, the Steering Committee decided to include a patient questionnaire developed by the experts at the European Organisation for Research and Treatment of Cancer (EORTC): the QLQ-C30, a multilingually verified quality of life questionnaire.

If you have any further questions, please contact the CIRSE Clinical Research Department at research@cirse.org

 

If you are a participating hospital you can 

here.