Clinical trial NCT03256994: CIRSE Registry for SIR-Spheres in France (CIRT-FR)
Official title: CIRSE Registry for SIR-Spheres in France (CIRT-FR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer
Lead sponsor: Cardiovascular and Interventional Radiological Society of Europe
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In a general manner and according to the Intent-To-Treat principle, no subject will be excluded from the analysis. The primary and secondary endpoint analysis will include all enrolled subjects in CIRT-FR.

However, patients who are considered for SIR-Spheres treatment but for whom it was decided that they would not be treated will not be included in the analysis.

Brief summary: Selective Internal Radiation Therapy (SIRT), also known as radioembolisation, is a minimal invasive, endovascular treatment for primary and secondary liver tumours. In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de Santé \[HAS\]). In order to evaluate the reimbursement after five years, all patients treated with SIR-Spheres will be entered into a registry that collects data on the real-life clinical application of SIRT and reports to the national authorities.

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.

In France, SIR-Spheres are listed as reimbursable by the national health authorities (Haute Autorité de Santé \[HAS\]). In order to evaluate the reimbursement after five years, all patients treated with SIR-Spheres will be entered into a registry that collects data on the real-life clinical application of SIRT and reports to the national authorities.

The goal of the research project is to gain a better understanding of the real-life clinical application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical practice. Secondary objectives will be to assess the observed treatment outcomes of SIRT with SIR-Spheres Y-90 resin microspheres in terms of safety, effectiveness, quality of life, technical considerations and diagnosis and treatment-related considerations.

To better understand the palliative aspect of the treatment, acquisition of the change in quality of life is included by means of EORTC's validated quality of life questionnaire QLQ C30 with accompanying HCC module to measure quality of life in patients with hepatocellular carcinoma.

Besides data collection on the initial treatment, it will be advised to collect follow-up data and quality of life data every three months for a minimum of 24 months after treatment.

CIRT-FR is a post-market, prospective, non-randomized, observational study. Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres as part of their treatment determined by the treating clinician. In no way will participation of the patient in the registry impact their treatment plan, or influence the quality of the treatment.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- Consent denied

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, treatment complications and laboratory assessments
timeFrame: Follow-up every 3 months until 24 months
measure: Effectiveness
timeFrame: Follow-up every 3 months until 24 months
measure: QLQ-C30
timeFrame: Every 3 months until 24 months
measure: Technical considerations
timeFrame: Baseline
measure: Diagnosis- and treatment-related considerations
timeFrame: Baseline
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Clichy
country: France
facility: Hôpital Beaujon
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: Chu de Dijon
city: Grenoble
country: France
facility: CHU de Grenoble Alpes
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: CHU de Lyon
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Nîmes
country: France
facility: CHU de Nimes
city: Paris
country: France
facility: Institut Gustave Roussy
city: Poitiers
country: France
facility: CHU de Poitiers
city: Strasbourg
country: France
facility: CHRU de Strasbourg
Study officials:
affiliation: Cardiovascular and Interventional Radiological Society of Europe
name: Valérie I Vilgrain, Prof
role: STUDY_CHAIR
affiliation: Cardiovascular and Interventional Radiological Society of Europe
name: Thomas I Helmberger, Prof
role: STUDY_CHAIR
References:
citation: Loffroy R, Ronot M, Greget M, Bouvier A, Mastier C, Sengel C, Tselikas L, Arnold D, Maleux G, Pelage JP, Pellerin O, Peynircioglu B, Sangro B, Schaefer N, Urdaniz M, Kaufmann N, Bilbao JI, Helmberger T, Vilgrain V; CIRT-FR Principal Investigators. Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France. Cardiovasc Intervent Radiol. 2021 Jan;44(1):36-49. doi: 10.1007/s00270-020-02643-x. Epub 2020 Sep 25.