CIEMAR: CIRSE Emprint Microwave Ablation Registry
Study Details
Study Description
Brief Summary
Observation of the clinical use of the Emprint Microwave Ablation System for the ablation of Liver Metastases of Colorectal Adenocarcinoma.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The CIRSE Emprint Microwave Ablation Registry (CIEMAR) aims to collect real-life data on the microwave ablation (MWA) of colorectal liver metastatic disease using the Emprint Microwave Ablation System.
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 will observe the use of the Emprint Microwave Ablation System and all patients included in CIEMAR will receive treatment with this device as their standard care for CRLM.
Primary endpoint: local tumour control in liver at 12 months after the microwave ablation treatment on a per lesion basis
Secondary objectives: 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; Economic aspects
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 will incorporate 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.
The registry is currently in design and it is planned to start patient inclusion in January 2020. The target is to enrol 1000 patients and patient enrolment will stop two years after the enrolment of the first patient. A follow-up period of three years has been defined by the CIEMAR Steering Committee.
Study Design
Outcome Measures
Primary Outcome Measures
- Local Tumor Control [12 months]
Local Tumor Control at 12 months on a per lesion basis
Secondary Outcome Measures
- Number of participants with acute and/or chronic adverse events according to the latest version of CTCAE [3 years]
Safety and Tolerability will be monitored before, during and after the microwave ablation treatment.
- Overall survival [3 years]
Time from observation until death due to any cause (or censoring)
- Overall disease-free-survival [3 years]
Time from observation until disease progression or death assessed by the investigators
- Hepatic disease-free-survival [3 years]
Time from observation until disease progression in the liver or death assessed by the investigators.
- Time to untreatable progression by thermal ablation [3 years]
Time from the treatment to the point when liver malignancies can no longer be treated by thermal ablation.
- Systemic cancer therapy vacation [3 years]
Time that participants can be removed from systemic cancer therapies following the microwave ablation treatment.
- Treatment specific quality of life [1 year]
Treatment specific quality of life will be assessed using the EORTC-QLQ-C30 questionnaire which includes 28 questions on a scale of 1 to 4 where 1 indicates lower impact of the disease on the patient's quality of life and 4 represents a high impact. Additionally 2 questions using a scale form 1 to 7 are used to generally assess the patient's quality of life where 1 represents poor quality of life and 7 represents an excellent quality of life.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years or older
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Proven colorectal liver metastases
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Treated with EMPRINT Microwave ablation system.
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Patient referred to MWA by a multidisciplinary tumour board.
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Signed Informed consent form
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Intention to treat all liver lesions with radical ablation
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Intention to completely treat (ablation, resection, SABR) all visible disease
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Maximum number of 9 liver lesions.
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Maximum diameter of the largest liver lesion does not exceed 3 cm.
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Maximum number of 5 lung nodules eligible to be radically treated.
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Patients treated with a liver first approach may be included if resection of the primary tumour is planned if applicable.
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Complete response of treated rectal tumour proven by imaging if applicable.
Exclusion Criteria:
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Life expectancy less than 6 months (palliative treatment)
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Extrahepatic metastases
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Ongoing infection (viral/bacterial)
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Pregnant women
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Patients with liver metastases that cannot be completely and safely treated
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Active cancers other than CRC
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Non-resected primary colon cancer
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Advanced liver disease or evidence of liver insufficiency
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Uncorrectable coagulopathy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CIRSE Cardiovascular and Interventional Radiological Society of Europe | Vienna | Austria | 1010 |
Sponsors and Collaborators
- Cardiovascular and Interventional Radiological Society of Europe
- Medtronic
Investigators
- Study Chair: Phillippe L. Pereira, PhD, Radiology, Minimally Invasive Therapies and Nuclear Medicine at SLK Clinics Heilbronn GmbH, Germany
- Study Chair: Thierry de Baère, PhD, Departement of therapeutic radiology, Institut Gustave Roussy, Villejuif, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIEMAR