CIRSE Registry for LifePearl Microspheres
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Number of indications that the device is being used for, as assessed by stage and previous treatment(s)
研究概览
简要总结
The application of transarterial chemoembolisation (TACE) using LifePearl Microspheres loaded with Irinotecan in liver-only or liver-dominant metastatic disease in patients with colorectal adenocarcinoma will be observed. The registry has the following objectives:
- map the exact indications that the device is being used for and at which stage in treatment it is being applied
- to assess observed treatment outcomes in terms of safety and effectiveness as well as trying to determine any predictive response factors
详细描述
CIREL will capture a broad spectrum of real clinical data on the delivery of transcatheter arterial chemoembolisation (TACE) using LifePearl Microspheres loaded with Irinotecan (LP-IRI) and the observed clinical outcomes. The aim of doing so is to improve our understanding of how LifePearl microspheres are administered as part of the standard treatment of colorectal adenocarcinoma with liver metastases in Europe. Ultimately, the collection of real-life data is intended to provide an evidence-base from which conclusions can be drawn on how to optimise treatment protocols and consequently the therapy outcome of TACE performed with LifePearl Microspheres.
The CIREL registry is a prospective multicentre observational (non-interventional) study. In order to meet the objective of collecting real-life data, all subjects receiving TACE with LifePearl Microspheres loaded with Irinotecan and fulfilling the inclusion criteria in all participating centres will be asked to participate. Patients are only asked to participate in the registry when they are treated with LifePearl Microspheres loaded with Irinotecan as part of the treatment determined by the treating clinician. In no way, will participation in the registry influence the way in which the patient is treated according to the treating clinician, or will it influence the quality of the treatment.
In order to measure changes in the quality of life of enrolled patients at different moments in time before and after treatment with LifePearl microspheres, CIREL will incorporate the EORTC QLQ-C30 questionnaire. The quality of life questionnaire is suggested to be offered to the patient at the following three points in time:
- Immediately (max. 1 week) before the treatment with LP-IRI
- 4-8 weeks after completion of the full treatment with LP-IRI
- 12-16 weeks after the completion of the full treatment with LP-IRI
Filling out the quality-of-life questionnaire is entirely voluntary for the patient. The patient will be offered to fill out the questionnaire in his/her mother tongue. The patient will have the choice to fill in the questionnaire either in hard copy or online via the electronic data capture system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with liver-only or liver-dominant metastatic disease in patients with colorectal adenocarcinoma
- •treatment with LifePearl Microspheres
- •signed informed consent form
- •18 years or older
排除标准
- •withdrawal of informed consent
结局指标
主要结局
Number of indications that the device is being used for, as assessed by stage and previous treatment(s)
时间窗: 2.5 years
The primary objective is to ultimately categorise observed usages as one of the following: * LifePearl as a first-line treatment * LifePearl as a consolidation or closing treatment with or without systemic therapy * Intensification of treatment with concomitant systemic therapy (objective: resectability and/or ablative therapy) * Salvage treatment in progressive patients pre-treated with systemic therapy, with or without concomitant systemic therapy * Combination treatment with ablation with a curative intent * Other
次要结局
- Number of participants with acute and/or chronic adverse events according to CTCAE version 4.03.(4 years)
- Time from observation until death due to any cause (or censoring)(4 years)
- Time from observation until disease progression or death(4 years)
- Time from observation until disease progression in the liver or death(4 years)
- Proportion of patients with reduction in tumor burden, as assessed by RECIST (v.1.1)(4 years)
- Number of patients with tumour shrinkage at > 20% or >30% at first tumour assessment (4 - 8 wks)(4 years)
- Nadir of tumour response over the time of observation(4 years)
- Number of patients with secondary resections or ablative treatments following initial treatment with LP-IRI(4 years)
- The quality of participants' lives, as assessed by the QLQ-C30 questionnaire (developed by EORTC)(4 years)