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The CIRSE Registry for SIR-Spheres Therapy (CIRT)

Radioembolisation is a rapidly growing treatment modality in Europe. Previous reports on the safety and efficacy of this procedure for the treatment of primary and secondary liver tumours are very promising, but more evidence on the treatment in a clinical setting is necessary. In order to further improve our understanding of this therapy, CIRSE initiated a registry that enables robust data collection on the real-life clinical application of SIR-Spheres microspheres: the CIRSE Registry for SIR-Spheres Therapy (CIRT).

The CIRSE Registry for SIR-Spheres Therapy (CIRT) is a European-wide registry that aims to prospectively collect data on SIR-Spheres therapies. Various European medical centres already use this therapy to treat liver tumours. While smaller studies have shown that this treatment can have a positive effect, the registry aims to investigate the real-life application of SIR-Spheres microspheres on a multinational scale.

CIRT Steering Committee
CIRT 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. José Ignacio Bilbao (Clínica Universidad de Navarra, Pamplona, Spain).

Steering Committee members  
Prof. José Ignacio Bilbao (Chair) Interventional radiology
Dr. Roberto Cianni Interventional radiology
Prof. Thomas Helmberger Interventional radiology
Dr. Graham Munneke Interventional radiology
Dr. Jean Pierre Pelage Interventional radiology
Prof. Bora Peynircioglu Interventional radiology
Prof. Geert Maleux Interventional radiology
Prof. Bruno Sangro Hepatology
Prof. Frank Kolligs Internal Medicine
Prof. Derek Manas Surgery
Prof. Samer Ezziddin Nuclear Medicine
Prof. Niklaus Schäfer Nuclear Medicine
Prof. Ricky Sharma Oncology
Prof. Dirk Arnold Oncology
Henk Tissing Non-voting member from Sirtex

 

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

 

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

 

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.

Methods
Data will be collected prospectively from medical centres in Europe via an electronic data capture (EDC) system. A certain level of experience with SIR-Spheres will be required from participating centres in order to exclude operators that are still in the learning phase of the procedure.

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.

Participation is closed
As of 1 June 2017, hospital participation has been closed in order to give hospitals time to enroll a sufficient number of patients. 31 December 2017 marked the end of the two-year patient enrolment period. 1052 patients have been enrolled into the registry. Follow-up inclusion will be done until 31 December 2019

 

   

Project Summary Document (PDF download)

If you are a participating hospital you can 

here.

 

 

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