
score remained stable between baseline (66.7%), treatment
(62.5%) and the first follow-up (66.7%).
Conclusion This interim analysis demonstrates that data
regarding safety and quality of life generated by ran-
domised-controlled trials is reflected when assessing the
real-world application of TARE.
Trial Registration Clinical Trials.gov NCT03256994.
Keywords Radioembolization Transarterial
radioembolization Yttrium-90 SIR-spheres
Interim analysis SIRT
Introduction
Transarterial radioembolization (TARE), also known as
selective internal radiation therapy (SIRT), with SIR-
Spheres Y-90 resin microspheres, is an endovascular pro-
cedure included within the interventional oncologic arma-
mentarium to treat primary and secondary liver tumours
[1–7].
CIRT-FR (CIRSE Registry for SIR-Spheres Therapy in
France; NCT03256994) was developed as a France-only
adaptation of the pan-European, prospective observational
study CIRT (NCT02305459) [8]. While CIRT [9] had only
collected data from one French hospital, CIRT-FR was
open to all French centres and designed to exhaustively
include as many patients in France as possible. Under the
condition that the present study was conducted in order to
collect data on the real-life clinical application of TARE
with SIR-SpheresÒ in France, reimbursement for liver-
only metastatic colorectal cancer (mCRC) was granted for
5 years by the French national health authorities (Haute
Autorite
´
de Sante
´
, HAS) in March 2017.
1
In March 2019,
based on the results of the phase III randomized controlled
trials SARAH [10] and SIRveNIB [11], HAS extended
reimbursement for patients with intermediate or advanced
hepatocellular carcinoma (HCC
2
). Final data from this
observational study will support French authorities in the
decision making on reimbursement considerations for
TARE beyond 2022.
This publication is the 200-patient interim analysis of
the prospective, post-market, observational study CIRT-
FR, with the objective to report on patient characteristics,
treatment details as well as safety and health-related quality
of life.
The primary objective was to observe the real-life
clinical application of TARE with SIR-Spheres Y-90 resin
microspheres in the context of the patients’ continuum of
care (please refer to Table 1). Secondary objectives were to
assess safety, toxicity, quality of life, technical considera-
tions and diagnosis and treatment-related considerations,
such as intention of treatment, prior and post-TARE
interventional procedures and/or systemic therapy.
Methods
Study Design/Setting
Patients for this 200-patient interim analysis were enrolled
from 11 centres between August 2017 and October 2019,
and follow-up data were collected until June 2020. All
hospitals in France that had performed TARE with SIR-
Spheres or were preparing to perform their first treatment
were invited to participate. Hence, 31 sites were invited to
participate, of which 4 declined participation, 4 were in the
contracting process at the time of this analysis and 22 sites
participated. Data were monitored by CIRSE remotely
every 3 months to verify data quality and completion, and
to identify any issues with patient inclusion and data col-
lection. This study was performed in accordance with the
Declaration of Helsinki and Good Clinical Practice
Guidelines and was approved by the CPP SUD-EST II
French Ethics Committee (N° ID-RCB: 2017-A01003-50).
Since this study is an offspring of the European observa-
tional study CIRT [9] and closely corresponds to its
methodology, please refer to the published methodology of
CIRT for a more detailed description of methods and
outcome measures [8].
14
Service de me
´
decine nucle
´
aire Et Imagerie mole
´
culaire,
Centre Hospitalier Universitaire de Lausanne, Rue du
Bugnon 46, CH-1011 Lausanne, Switzerland
15
Clinical Research Department, Cardiovascular and
Interventional Radiological Society of Europe, Neutorgasse
9, 1010 Vienna, Austria
16
Interventional Radiology, Clı
´
nica Universidad de Navarra,
Avenida Pio XII, no 36, 31008 Pamplona, Spain
17
Department of Radiology, Neuroradiology and Minimal-
Invasive Therapy, Klinikum Bogenhausen, Englschalkinger
Str. 77, 81925 Munich, Germany
1
HAS (2015). Avis de la CNEDiMTS sur SIR-Spheres. Retrieved
March 2, 2017, from https://www.has-sante.fr/portail/jcms/c_
2023879/fr/sir-spheres
2
HAS (2018). Avis de la CNEDiMTS sur SIR-Spheres. Retrieved
October 7, 2019, from https://www.has-sante.fr/jcms/c_2896412/fr/
sir-spheres
R. Loffroy et al.: Short-term Safety and Quality of Life Outcomes...
123