CIRSE Registry for SIR-Spheres Therapy

Completed

• Conditions: Liver Carcinoma
• Interventions: Device: Yttrium-90 loaded SIR-Spheres microspheres; Behavioral: QLQ-C30 with HCC module

• Registration Number: NCT02305459
• Lead Sponsor: Cardiovascular and Interventional Radiological Society of Europe

Brief 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

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. 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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-11-27
• Study First Posted: 2014-12-02
• Primary Completion: 2018-01-01
• Status Verified: 2020-01
• Study Completion: 2020-01-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1051

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with Radioembolisation	QLQ-C30 with HCC module	All Patients treated with Radioembolisation with yttrium-90 loaded SIR-Spheres microspheres are asked to be enrolled. In no way will participation in the registry influence the way in which the patient is treated or will it influence the quality of the treatment. 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 the Hepatocellular carcinoma (HCC) Module to measure changes in the quality of life of the patient.
Patients treated with Radioembolisation	Yttrium-90 loaded SIR-Spheres microspheres	All Patients treated with Radioembolisation with yttrium-90 loaded SIR-Spheres microspheres are asked to be enrolled. In no way will participation in the registry influence the way in which the patient is treated or will it influence the quality of the treatment. 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 the Hepatocellular carcinoma (HCC) Module to measure changes in the quality of life of the patient.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse events	Every 3 months until 24 months	Adverse events per follow-up
QLQ-C30	Every 3 months until 24 months	Quality of life using QLQ-C30 from baseline until 24 months
Overall survival	Every 3 months until 24 months	Time till death
Hepatic PFS	Every 3 months until 24 months	Time to progression
PFS	Every 3 months until 24 months	Time to progression

Trial Locations

Locations (1)

Cardiovascular and Interventional Radiological Society of Europe; 🇦🇹 Vienna, Austria