Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy.
- Conditions
- Colorectal Cancer
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Colorectal cancer Hepatic metastases unresectable by classical surgery Performance status < 2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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)
CHU d'Angers
🇫🇷Angers, France
Centre Saint Michel
🇫🇷Angoulême, France
CHU de Bordeaux
🇫🇷Bordeaux, France
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
🇫🇷Bordeaux, France
Hopital Béclère
🇫🇷Clamart, France
Hopital Sub-Urbain du Bouscat
🇫🇷Le Bouscat, France
Hopital de la Croix Rousse
🇫🇷Lyon, France
Hopital Saint Eloi
🇫🇷Montpellier, France
Centre Hospitalier
🇫🇷Niort, France
Centre de Radiothérapie et d'Oncologie Médicale
🇫🇷Pau, France
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