CIRT

CIRSE Registry for SIR-Spheres Therapy

Status: closed

Study summary | Endpoints | Methods | Patient enrolment | Outcomes | 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 was 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

CIRT was a prospective, multicentre, single-device, observational study of patients with hepatic malignancies treated with TARE with Y90 resin microspheres as standard of care. Sites were invited if they met the minimum selection criteria of at least 40 treatments in total, with a minimum of ten procedures within 12 months prior to invitation. From August 2014 to April 2017, 27 sites were enrolled and included patients. Data was collected prospectively from medical centres in Europe via an electronic data capture (EDC) system.

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.

Outcomes

The full report on the outcomes of CIRT can be found here.

During the observation period, 495 (48.2%) patients died and 349 (33.9%) were lost to follow up. 26 (2.5%) patients had less than 2 years of follow-up but no recorded reason for non-completion. 157 (15.3%) patients were alive and completed the 2-year follow-up period.

Median overall survival for patients following TARE was 16.5 months (95% CI 14.2–19.3) for HCC and 14.7 months (95% CI 10.9–17.9) for ICC. For liver metastases, median OS for mCRC was 9.8 months (95% CI 8.3–12.9), 5.6 months (95% CI 4.1–6.6) for pancreatic cancer metastases, 10.6 months (95% CI 7.3–14.4) for breast cancer, 14.6 months (95% CI 7.3–21.4) for melanoma and 33.1 months (95% 22.1–nr) for neuroendocrine tumours. Univariable analyses showed that extra-hepatic disease, ECOG status ≥0, presence of cirrhosis and ascites were associated with a lower survival rate. Unilateral malignancies had a better survival outcome than bilobar malignancies and a higher tumour burden was negatively associated with overall survival.

Across the entire cohort, the 30-day mortality rate of patients that received TARE was 1.0% (n = 10). Serious adverse events (SAE, grade 3 and 4) within 30 days of treatment were found in less than 2.5% of the patients. SAEs such as gastritis, gastrointestinal ulcerations, radiation cholecystitis and radioembolization-induced liver disease (REILD) occurred in less than 0.3% of the total patient cohort.

Steering Committee

Links

https://clinicaltrials.gov/ct2/show/NCT02305459

Schaefer N, Grözinger G, Pech M, Pfammatter T, Soydal C, Arnold D, Kolligs F, Maleux G, Munneke G, Peynircioglu B, Sangro B, Pereira H, Zeka B, de Jong N, Helmberger T; 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.

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, Pfammatter T, Arnold D, Cianni R, Maleux G, Munneke G, Pellerin O, Peynircioglu B, Sangro B, Schaefer N, de Jong N, Bilbao JI; On behalf of the CIRT Steering Committee; On behalf of the CIRT Principal Investigators. 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. 2021 Jan;44(1):21-35. DOI: 10.1007/s00270-020-02642-y. PMID: 32959085