CIRSE Emprint Microwave Ablation Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 38
- 主要终点
- Local Tumor Control
研究概览
简要总结
Observation of the clinical use of the Emprint Microwave Ablation System for the ablation of Liver Metastases of Colorectal Adenocarcinoma.
详细描述
The CIRSE Emprint Microwave Ablation Registry (CIEMAR) is collecting real-life data on the microwave ablation (MWA) of colorectal liver metastatic disease using the Emprint Microwave Ablation System (full study duration) or Emprint HP Microwave Ablation System (from 2021 onwards).
CIEMAR is a prospective, single-arm, multi-centre observational (non-interventional) study with the objective to observe the "real-life" use of MWA in Europe. The study is observing the use of the Emprint or Emprint HP Microwave Ablation System and all patients included in CIEMAR are receiving treatment with this device as their standard care for CRLM.
Primary endpoint: local tumour control in liver at 12 months after MWA on a per lesion basis
Secondary endpoints: Safety; Overall survival; Overall disease-free survival; Hepatic disease-free survival; Time to untreatable progression by thermal ablation; Systemic cancer therapy vacation; Quality of life; Adverse events and toxicity
In order to measure changes in the quality of life of enrolled patients at different moments in time before and after treatment with MWA, CIEMAR is collecting quality of life data using the EORTC QLQ-C30 questionnaire. 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •18 years or older
- •Proven colorectal liver metastases either histologically proven or diagnosed by imaging in a patient with known colorectal cancer
- •Treated with the Emprint or Emprint HP Microwave ablation system
- •Patient referred to MWA by a multidisciplinary tumour board
- •Signed informed consent form
- •Intention to completely treat (ablation, resection, SBRT) all visible disease within 8 weeks
- •Maximum number of 9 total liver lesions
- •All liver lesions must be local treatment-naive
- •Maximum diameter of the largest liver lesion treated with MWA must not exceed 3cm
- •Maximum diameter of lesions treated surgically may exceed this limitation
- •Maximum number of 5 lung nodules eligible to be treated
- •Patients may receive simultaneous liver resection and microwave ablation
- •Patients may have received previous systemic therapy
- •Patients must not have received surgical resection or thermal ablation for other liver lesions in the last 3 months before inclusion
- •Patients treated with a liver-first approach may be included if treatment of the primary tumour is planned
- •If applicable: complete response of treated rectal tumour proven by imaging
排除标准
- •Life expectancy less than 6 months (palliative treatment)
- •Extrahepatic metastases with the exception of a maximum of 5 lung nodules
- •Ongoing infection (viral/bacterial)
- •Patients receiving simultaneous bowel surgery and microwave ablation
- •Patients receiving simultaneous IRE, RFA, SBRT, Cryoablation, HIFU or other local treatment than resection
- •Pregnancy
- •Patients with liver metastases that cannot be completely and safely treated
- •Active cancers other than CRC
- •Non-resected primary colon cancer
- •Advanced liver disease or evidence of liver insufficiency
结局指标
主要结局
Local Tumor Control
时间窗: 12 months
Local Tumor Control at 12 months on a per lesion basis
次要结局
- Hepatic disease-free-survival(3 years)
- Systemic cancer therapy vacation(3 years)
- Overall disease-free-survival(3 years)
- Overall survival(3 years)
- Number of participants with acute and/or chronic adverse events according to the latest version of CTCAE(3 years)
- Time to untreatable progression by thermal ablation(3 years)
- Treatment specific quality of life(1 year)