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

Colorectal Cancer Clinical Trial

— ARF2003  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210106
• Other study ID #: IB2003-11
• Secondary ID: ARF2003
• Status: Completed
• Phase: N/A
• Start date: June 2003
• Est. completion date: May 2010

Study information

• Verified date: April 2021
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm Metastasis

Intervention

Device:
• Ablathermy

Locations

Country	Name	City	State
France	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	Clinique Francheville	Périgueux
France	Clinique Mutualiste de Pessac	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

References & Publications (1)

Evrard S, Rivoire M, Arnaud J-, Lermite E, Bellera C, Fonck M, Becouarn Y, Lalet C, Puildo M, Mathoulin-Pelissier S. Unresectable colorectal cancer liver metastases treated by intraoperative radiofrequency ablation with or without resection. Br J Surg. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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