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CIRSE Registry for SIR-Spheres in France (CIRT-FR)

Completed
Conditions
Liver Cancer
Registration Number
NCT03256994
Lead Sponsor
Cardiovascular and Interventional Radiological Society of Europe
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
332
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Description of the clinical context in which SIR-Spheres are appliedBaseline, follow-up every 3 months until 24 months

Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures

Secondary Outcome Measures
NameTimeMethod
EffectivenessFollow-up every 3 months until 24 months

Based on overall survival (OS), progression free survival (PFS), liver specific PFS

Diagnosis- and treatment-related considerationsBaseline

Assessed by type of liver cancer, intention of the treatment, prior hepatic procedures, associated systemic therapy and post-SIRT hepatic procedures

QLQ-C30Every 3 months until 24 months

Quality of life using QLQ-C30 from baseline until 24 months

Technical considerationsBaseline

Assessed by patient related characteristics, treatment related characteristics, treatment administration and procedure-related outcomes

Adverse events, treatment complications and laboratory assessmentsFollow-up every 3 months until 24 months

Adverse events measured according to CTCAE 4.03, treatment complications reported bz investigators and abnormal laboratory assessments according to CTCAE 4.03

Trial Locations

Locations (13)

CHRU de Strasbourg

🇫🇷

Strasbourg, France

CHU de Lyon

🇫🇷

Lyon, France

CHU de Nimes

🇫🇷

Nîmes, France

CHU de Poitiers

🇫🇷

Poitiers, France

Hôpital Beaujon

🇫🇷

Clichy, France

Chu de Dijon

🇫🇷

Dijon, France

CHU d'Angers

🇫🇷

Angers, France

Institut Paoli-Calmettes

🇫🇷

Marseille, France

Institut Gustave Roussy

🇫🇷

Paris, France

CHU de Bordeaux

🇫🇷

Bordeaux, France

CHU de Grenoble Alpes

🇫🇷

Grenoble, France

Hôpital Henri Mondor

🇫🇷

Créteil, France

Centre Léon Bérard

🇫🇷

Lyon, France

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