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临床试验/NCT02305459
NCT02305459已完成不适用

CIRSE Registry for SIR-Spheres Therapy

Cardiovascular and Interventional Radiological Society of Europe2 个研究点 分布在 1 个国家目标入组 1,051 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,051
试验地点
2
主要终点
Description of the clinical context in which SIR-Spheres are applied

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Treatment of liver tumour with SIR-spheres microspheres
  • Primary or secondary liver tumours
  • Signed informed consent form
  • 18 years or older

排除标准

  • Under 18 years

研究组 & 干预措施

Patients treated with Radioembolisation

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.

干预措施: Yttrium-90 loaded SIR-Spheres microspheres (Device)

Patients treated with Radioembolisation

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.

干预措施: QLQ-C30 with HCC module (Behavioral)

结局指标

主要结局

Description of the clinical context in which SIR-Spheres are applied

时间窗: Baseline, follow-up every 3 months until 24 months

Context of systemic therapy; intention of treatment; prior hepatic procedures; post hepatic procedures

次要结局

  • Adverse events(Every 3 months until 24 months)
  • QLQ-C30(Every 3 months until 24 months)
  • Overall survival(Every 3 months until 24 months)
  • Hepatic PFS(Every 3 months until 24 months)
  • PFS(Every 3 months until 24 months)

研究者

发起方
Cardiovascular and Interventional Radiological Society of Europe
申办方类型
Other
责任方
Sponsor

研究点 (2)

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