Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy.

Study Overview
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Brief Summary
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The hypothesis is that radiofrequency ablation combined or not with resection may allow a local control (the liver) in patients suffering from unresectable colorectal liver metastases. Patients may have benefit or not from a preoperative (neoadjuvant) chemotherapy.

Official Title
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Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy. A Phase 2 Study.

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: Ablathermy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Colorectal cancer Hepatic metastases unresectable by classical surgery Performance status < 2 Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoperative radiofrequency ablation (IRFA)<br>IRFA treatment, either with or without resection, was performed at laparotomy within 28 days of inclusion in the study. The type of IRFA current generator and probes, and whether or not resection was performed, was at the discretion of the surgeon. | Device: Ablathermy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Hepatic Response Rate at 3 Months | Complete hepatic response (CHR) rate was defined as the absence of new hepatic lesions or contrast enhancement at the ablation and resection sites on CT performed at 2 and 3 months. CHR at 3 months was reported | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | OS was defined as the time from the treatment initiation to death due to any cause. Participants without documented death were censored at the date of the last follow-up or last patient contact. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. 1-year and 2-year OS rate were reported. | at 1 and 2 years | 
| Event-free Survival | Event-free survival was measured from the date of intervention to the date of the first of the following events: initial failure, disease progression (hepatic or distant) or death (all causes). Patients who were alive and event-free were consored at the last documented date of follow-up. 1-year and 2-years EFS rates were reported. | at 1 and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofrequency ablation, Colorectal cancer, Liver metastases