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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cancer
• Intervention / Treatment: Device: Yttrium-90 loaded SIR-Spheres microspheres; Behavioral: QLQ-C30 with HCC module

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.

• Study Type: Observational
• Enrollment (Actual): 332

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHU d'ANGERS
  • Bordeaux, France
    • CHU de Bordeaux
  • Clichy, France
    • Hopital Beaujon
  • Créteil, France
    • Hopital Henri Mondor
  • Dijon, France
    • CHU de Dijon
  • Grenoble, France
    • CHU de Grenoble Alpes
  • Lyon, France
    • Centre Leon Berard
  • Lyon, France
    • Chu de Lyon
  • Marseille, France
    • Institut Paoli-Calmettes
  • Nîmes, France
    • CHU de Nîmes
  • Paris, France
    • Institut Gustave Roussy
  • Poitiers, France
    • CHU de Poitiers
  • Strasbourg, France
    • CHRU de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the clinical context in which SIR-Spheres are applied	Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures	Baseline, follow-up every 3 months until 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events, treatment complications and laboratory assessments	Adverse events measured according to CTCAE 4.03, treatment complications reported bz investigators and abnormal laboratory assessments according to CTCAE 4.03	Follow-up every 3 months until 24 months
Effectiveness	Based on overall survival (OS), progression free survival (PFS), liver specific PFS	Follow-up every 3 months until 24 months
QLQ-C30	Quality of life using QLQ-C30 from baseline until 24 months	Every 3 months until 24 months
Technical considerations	Assessed by patient related characteristics, treatment related characteristics, treatment administration and procedure-related outcomes	Baseline
Diagnosis- and treatment-related considerations	Assessed by type of liver cancer, intention of the treatment, prior hepatic procedures, associated systemic therapy and post-SIRT hepatic procedures	Baseline

Collaborators and Investigators

• Sponsor: Cardiovascular and Interventional Radiological Society of Europe
• Investigators: Study Chair: Valérie I Vilgrain, Prof, Cardiovascular and Interventional Radiological Society of Europe; Study Chair: Thomas I Helmberger, Prof, Cardiovascular and Interventional Radiological Society of Europe

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: CIRT-FR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No