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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Device: Ablathermy

• Registration Number: NCT00210106
• Lead Sponsor: Institut Bergonié

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2008-12
• Study Completion: 2010-05
• Results First Submitted: 2021-03-19
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-27
• Last Update Submitted: 2021-04-27
• Results First Posted: 2021-05-18
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Colorectal cancer Hepatic metastases unresectable by classical surgery Performance status < 2

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative radiofrequency ablation (IRFA)	Ablathermy	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.

Primary Outcome Measures

Name	Time	Method
Complete Hepatic Response Rate at 3 Months	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	at 1 and 2 years	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.
Event-free Survival	at 1 and 2 years	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.

Trial Locations

Locations (12)

Centre Saint Michel; 🇫🇷 Angoulême, France

Hopital Béclère; 🇫🇷 Clamart, France

Centre Hospitalier; 🇫🇷 Niort, France

CHU d'Angers; 🇫🇷 Angers, France

Hopital Saint Eloi; 🇫🇷 Montpellier, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest; 🇫🇷 Bordeaux, France

Hopital de la Croix Rousse; 🇫🇷 Lyon, France

Hopital Sub-Urbain du Bouscat; 🇫🇷 Le Bouscat, France

Clinique Mutualiste de Pessac; 🇫🇷 Pessac, France

Clinique Francheville; 🇫🇷 Périgueux, France

Centre de Radiothérapie et d'Oncologie Médicale; 🇫🇷 Pau, France