Clinical trial NCT02305459: CIRSE Registry for SIR-Spheres Therapy
Official title: CIRSE Registry for SIR-Spheres Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Carcinoma
Keywords: SIRT
microcatheter
primary liver tumor
secondary liver tumor
radioembolisation
QLQ-C30
CIRSE
Lead sponsor: Cardiovascular and Interventional Radiological Society of Europe
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 1051
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres as part of the treatment determined by the treating clinician.

Brief summary: The administration of SIR-Spheres microspheres (yttrium-90 resin microspheres) is a form of selective internal radiation therapy (SIRT) for the treatment of patients with primary and secondary liver tumours. The primary objective is to observe the real-life clinical application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical practice. Secondary objectives are to observe safety and effectiveness of SIR-Spheres treatment in terms of adverse events, Overall Survival (OS), Progression-free survival (PFS), technical considerations, liver PFS and Quality of Life (QoL) + subgroup analyses

Detailed description: Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. Following administration, 94% of the radiation is delivered in 11 days. Previous reports on the safety and efficacy of yttrium-90 resin microspheres for the treatment of primary and secondary liver tumours are very promising. In order to further improve the understanding of this therapy in its true clinical setting, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) initiated the CIRSE Registry for SIR-Spheres Therapy (CIRT), a phase 4 observational study that aims to collect robust data on the real-life clinical practice of radioembolisation with SIR-Spheres microspheres. Further, using the quality of life questionnaire QLQ-C30 with its hepatocellular carcinoma module (developed and verified by the European Organisation of Research and Treatment of Cancer (EORTC)), CIRT aims to collect data on the quality of life of patients treated with SIR-Spheres microspheres.

Eligibility criteria: Inclusion Criteria:

* Treatment of liver tumour with SIR-spheres microspheres
* Primary or secondary liver tumours
* Signed informed consent form
* 18 years or older

Exclusion criteria

* Under 18 years

Primary outcomes:
measure: Description of the clinical context in which SIR-Spheres are applied
timeFrame: Baseline, follow-up every 3 months until 24 months
Secondary outcomes:
measure: Adverse events
timeFrame: Every 3 months until 24 months
measure: QLQ-C30
timeFrame: Every 3 months until 24 months
measure: Overall survival
timeFrame: Every 3 months until 24 months
measure: PFS
timeFrame: Every 3 months until 24 months
measure: Hepatic PFS
timeFrame: Every 3 months until 24 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Cardiovascular and Interventional Radiological Society of Europe
Study officials:
affiliation: München Klinik Bogenhausen,Englschalkinger Str. 77, D-81925 München
name: Thomas Helmberger, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Epub 2020 Sep 21.
citation: 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 Apr 22;9(4):e16296. doi: 10.2196/16296.