CIRT - CIRSE Registry for SIR-Spheres Therapy

Status: closed

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

Study summary

Radioembolisation 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 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. The registry aims to investigate the real-life application of SIR-Spheres microspheres on a multinational scale.

Endpoints

Primary end point

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 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 has been included in the study.

Safety

• adverse events

Effectiveness

• overall Survival (OS)
• progression free survival (PFS) by investigator
• liver specific PFS by investigator
• imaging response

Quality of life

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

Methods

Data is being 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 are still in the learning phase of the procedure.

Patient enrolment

As of December 31, 2019 data collection has been completed. 1,036 patients have been included in the study, representing 8 countries and 27 hospitals. Patients have been followed up for 24 months. Data is now under review by the Steering Committee. Publications can be expected in the third quarter of 2020.

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