CIRT

CIrse Registry for SIR-Spheres Therapy

Status: closed

Study summary | Endpoints | Patient enrolment |  CIRT Steering Committee | Publications

Study summary

Radioembolization is a rapidly growing treatment modality in Europe. Although data on the safety and efficacy of this procedure for the treatment of primary and secondary liver tumours is available, more evidence on the treatment in a clinical setting is necessary. Therefore, CIRSE initiated a registry that enabled 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 prospectively collected data on SIR-Spheres therapies with the goal to investigate the real-life application of SIR-Spheres microspheres on a multinational scale.

Endpoints

Primary end point

The primary objective was 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 were classified according to the following categories:

• Type of liver cancer
• Intention of treatment
• Prior hepatic procedures
• Associated systemic therapy
• Post-SIRT hepatic procedures

Secondary end points

In addition to observing the real-life application of CIRT, the Steering Committee is also very interested in data on the safety and effectiveness of the treatment. Furthermore, to observe the palliative aspect of SIRT, a quality of life questionnaire was included in the study.

Safety

• Adverse events

Effectiveness

• Overall Survival (OS)
• Progression free survival (PFS) by investigator
• Liver specific PFS by investigator

Quality of life

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

Methods

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

Patient enrolment

As of December 31, 2019 data collection has been completed. 1,036 patients were included in the study, representing 8 countries and 27 hospitals, of which 1,027 were included in the analysis.

Steering Committee

Helmberger T, Arnold D, Bilbao JI, de Jong N, Maleux G, Nordlund A, Peynircioglu B, Sangro B, Sharma RA, Walk A, Clinical Application of Radioembolization in Hepatic Malignancies: Protocol for a Prospective Multicenter Observational Study, JMIR Res Protoc 2020;9(4):e16296, DOI: 10.2196/16296, PMID: 32319960.

Helmberger, T, Golfieri, R, Pech, M, et al. Clinical Application of Trans-Arterial Radioembolization in Hepatic Malignancies in Europe: First Results from the Prospective Multicentre Observational Study CIRSE Registry for SIR-Spheres Therapy (CIRT). Cardiovasc Intervent Radiol (2020). DOI: 10.1007/soo270-020-02642-y, PMID: 32959085

Schaefer N, Grözinger G, Pech M, Pfammatter T, et al.; On behalf of the CIRT Steering Committee; On behalf of the CIRT Principal Investigators. Prognostic Factors for Effectiveness Outcomes After Transarterial Radioembolization in Metastatic Colorectal Cancer: Results From the Multicentre Observational Study CIRT. Clin Colorectal Cancer. 2022 Dec;21(4):285-296. DOI:10.1016/j.clcc.2022.09.002. PMID: 36270925

Kolligs F, Arnold D, Golfieri R, Pech M, et al.; On behalf of the CIRT Steering Committee; On behalf of the CIRT Principal Investigators. Factors impacting survival after transarterial radioembolization in patients with hepatocellular carcinoma: Results from the prospective CIRT study. JHEP Rep. 2022 Nov 25;5(2):100633. DOI: 10.1016/j.jhepr.2022.100633. PMID: 36593888

Maleux G, Albrecht T, Arnold D, Bargellini I, et al; On behalf of the CIRT Steering Committee; On behalf of the CIRT Principal Investigators. Predictive Factors for Adverse Event Outcomes After Transarterial Radioembolization with Yttrium-90 Resin Microspheres in Europe: Results from the Prospective Observational CIRT Study. Cardiovasc Intervent Radiol. Online 2023.