CIRSE Registry for SIR-Spheres Therapy

Liver Carcinoma Clinical Trial

— CIRT  

Official title:

CIRSE Registry for SIR-Spheres Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305459
• Other study ID #: CIRSECIRT
• Status: Completed
• Start date: November 2014
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2020
• Source: Cardiovascular and Interventional Radiological Society of Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The administration of SIR-Spheres microspheres (yttrium-90 resin microspheres) is a form of selective internal radiation therapy (SIRT) for the treatment of patients with primary and secondary liver tumours. The primary objective is to observe the real-life clinical application of radioembolisation with SIR-Spheres and the impact of the treatment in clinical practice. Secondary objectives are to observe safety and effectiveness of SIR-Spheres treatment in terms of adverse events, Overall Survival (OS), Progression-free survival (PFS), technical considerations, liver PFS and Quality of Life (QoL) + subgroup analyses

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. Previous reports on the safety and efficacy of yttrium-90 resin microspheres for the treatment of primary and secondary liver tumours are very promising. In order to further improve the understanding of this therapy in its true clinical setting, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) initiated the CIRSE Registry for SIR-Spheres Therapy (CIRT), a phase 4 observational study that aims to collect robust data on the real-life clinical practice of radioembolisation with SIR-Spheres microspheres. Further, using the quality of life questionnaire QLQ-C30 with its hepatocellular carcinoma module (developed and verified by the European Organisation of Research and Treatment of Cancer (EORTC)), CIRT aims to collect data on the quality of life of patients treated with SIR-Spheres microspheres.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1051
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Treatment of liver tumour with SIR-spheres microspheres

• Primary or secondary liver tumours

• Signed informed consent form

• 18 years or older

Exclusion criteria

• Under 18 years

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Carcinoma

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 will incorporate a quality-of-life questionnaire. CIRT 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
Austria	Cardiovascular and Interventional Radiological Society of Europe	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Cardiovascular and Interventional Radiological Society of Europe

Country where clinical trial is conducted

Austria, 

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	Adverse events per 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	Overall survival	Time till death	Every 3 months until 24 months
Secondary	PFS	Time to progression	Every 3 months until 24 months
Secondary	Hepatic PFS	Time to progression	Every 3 months until 24 months