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

Liver Cancer Clinical Trial

— CIRT-FR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256994
• Other study ID #: CIRT-FR
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2022
• Source: Cardiovascular and Interventional Radiological Society of Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Device:
• Yttrium-90 loaded SIR-Spheres microspheres
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.

Behavioral:
• QLQ-C30 with HCC module
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

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	CHU de Bordeaux	Bordeaux
France	Hôpital Beaujon	Clichy
France	Hôpital Henri Mondor	Créteil
France	Chu de Dijon	Dijon
France	CHU de Grenoble Alpes	Grenoble
France	Centre Léon Bérard	Lyon
France	CHU de Lyon	Lyon
France	Institut Paoli-Calmettes	Marseille
France	CHU de Nimes	Nîmes
France	Institut Gustave Roussy	Paris
France	CHU de Poitiers	Poitiers
France	CHRU de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Cardiovascular and Interventional Radiological Society of Europe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Effectiveness	Based on overall survival (OS), progression free survival (PFS), liver specific PFS	Follow-up every 3 months until 24 months
Secondary	QLQ-C30	Quality of life using QLQ-C30 from baseline until 24 months	Every 3 months until 24 months
Secondary	Technical considerations	Assessed by patient related characteristics, treatment related characteristics, treatment administration and procedure-related outcomes	Baseline
Secondary	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