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

NCT03256994 | Completed DMC

• 1 other identifier: CIRT-FR
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 13

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Adverse events, treatment complications and laboratory assessments

  Follow-up every 3 months until 24 months

• Effectiveness

  Follow-up every 3 months until 24 months

• QLQ-C30

  Every 3 months until 24 months

• Technical considerations

  Baseline

• Diagnosis- and treatment-related considerations

  Baseline

Interventions

Yttrium-90 loaded SIR-Spheres microspheres DEVICE

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. SIR-Spheres microspheres are manufactured by Sirtex Medical.

QLQ-C30 with HCC module BEHAVIORAL

In order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT-FR will incorporate a quality-of-life questionnaire. CIRT-FR will be using EORTC's QLQ-C30 with HCC Module to measure changes in the quality of life of the patient. The quality-of-life questionnaire will be offered to the patient before the treatment, shortly after the treatment (as soon as possible) and at every follow-up. Filling out the quality-of-life questionnaire is entirely voluntary for the patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Consent denied

Sponsors & Collaborators

• Cardiovascular and Interventional Radiological Society of Europe: lead

Study Sites (13)

CHU d'Angers

Angers, France

Location

CHU de Bordeaux

Bordeaux, France

Location

Hôpital Beaujon

Clichy, France

Location

Hôpital Henri Mondor

Créteil, France

Location

Chu de Dijon

Dijon, France

Location

CHU de Grenoble Alpes

Grenoble, France

Location

Centre Léon Bérard

Lyon, France

Location

CHU de Lyon

Lyon, France

Location

Institut Paoli-Calmettes

Marseille, France

Location

CHU de Nimes

Nîmes, France

Location

Institut Gustave Roussy

Paris, France

Location

CHU de Poitiers

Poitiers, France

Location

CHRU de Strasbourg

Strasbourg, France

Location

Related Publications (2)

• Reimer P, Vilgrain V, Arnold D, Balli T, Golfieri R, Loffroy R, Mosconi C, Ronot M, Sengel C, Schaefer N, Maleux G, Munneke G, Peynircioglu B, Sangro B, Kaufmann N, Urdaniz M, Pereira H, de Jong N, Helmberger T. Factors Impacting Survival After Transarterial Radioembolization in Patients with Unresectable Intrahepatic Cholangiocarcinoma: A Combined Analysis of the Prospective CIRT Studies. Cardiovasc Intervent Radiol. 2024 Mar;47(3):310-324. doi: 10.1007/s00270-023-03657-x. Epub 2024 Feb 6.

  PMID: 38321223 DERIVED

• 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.

  PMID: 32975600 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Valérie I Vilgrain, Prof

  Cardiovascular and Interventional Radiological Society of Europe

  STUDY CHAIR

• Thomas I Helmberger, Prof

  Cardiovascular and Interventional Radiological Society of Europe

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 22, 2017
• Study Start: August 1, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2022
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (13)