Back to resultsTreatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy. (ARF2003)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ablathermy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Radiofrequency ablation, Colorectal cancer, Liver metastases
Eligibility Criteria
Inclusion Criteria: Colorectal cancer Hepatic metastases unresectable by classical surgery Performance status < 2 Exclusion Criteria: -
Sites / Locations
- CHU d'Angers
- Centre Saint Michel
- CHU de Bordeaux
- Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
- Hopital Béclère
- Hopital Sub-Urbain du Bouscat
- Hopital de la Croix Rousse
- Hopital Saint Eloi
- Centre Hospitalier
- Centre de Radiothérapie et d'Oncologie Médicale
- Clinique Mutualiste de Pessac
- Clinique Francheville
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intraoperative radiofrequency ablation (IRFA)
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00210106
Brief Title
Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Radiofrequency ablation, Colorectal cancer, Liver metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraoperative radiofrequency ablation (IRFA)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ablathermy
Primary Outcome Measure Information:
Title
Complete Hepatic Response Rate at 3 Months
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
at 1 and 2 years
Title
Event-free Survival
Description
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.
Time Frame
at 1 and 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Colorectal cancer Hepatic metastases unresectable by classical surgery Performance status < 2
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge EVRARD, Pr
Organizational Affiliation
Institut Bergonié
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Centre Saint Michel
City
Angoulême
ZIP/Postal Code
16000
Country
France
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Béclère
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hopital Sub-Urbain du Bouscat
City
Le Bouscat
ZIP/Postal Code
33110
Country
France
Facility Name
Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Hopital Saint Eloi
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Centre Hospitalier
City
Niort
ZIP/Postal Code
79000
Country
France
Facility Name
Centre de Radiothérapie et d'Oncologie Médicale
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Clinique Mutualiste de Pessac
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Clinique Francheville
City
Périgueux
ZIP/Postal Code
24000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22396054
Citation
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. 2012 Apr;99(4):558-65. doi: 10.1002/bjs.8724. No abstract available.
Results Reference
result
Learn more about this trial
Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy.
We'll reach out to this number within 24 hrs