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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Liver Cancer

Intervention / Treatment
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* Device: Yttrium-90 loaded SIR-Spheres microspheres
* Behavioral: QLQ-C30 with HCC module


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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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 |