NCT00210106

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2003

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
11.1 years until next milestone

Results Posted

Study results publicly available

May 18, 2021

Completed
Last Updated

May 18, 2021

Status Verified

April 1, 2021

Enrollment Period

5.5 years

First QC Date

September 12, 2005

Results QC Date

March 19, 2021

Last Update Submit

April 27, 2021

Conditions

Colorectal Cancer

Keywords

Radiofrequency ablationColorectal cancerLiver metastases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Overall Survival

    at 1 and 2 years

  • Event-free Survival

    at 1 and 2 years

Study Arms (1)

Intraoperative radiofrequency ablation (IRFA)

EXPERIMENTAL

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

Interventions

AblathermyDEVICE
Intraoperative radiofrequency ablation (IRFA)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU d'Angers

Angers, 49000, France

Location

Centre Saint Michel

Angoulême, 16000, France

Location

CHU de Bordeaux

Bordeaux, 33076, France

Location

Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

Bordeaux, 33076, France

Location

Hopital Béclère

Clamart, 92140, France

Location

Hopital Sub-Urbain du Bouscat

Le Bouscat, 33110, France

Location

Hopital de la Croix Rousse

Lyon, 69000, France

Location

Hopital Saint Eloi

Montpellier, 34000, France

Location

Centre Hospitalier

Niort, 79000, France

Location

Centre de Radiothérapie et d'Oncologie Médicale

Pau, 64000, France

Location

Clinique Mutualiste de Pessac

Pessac, 33600, France

Location

Clinique Francheville

Périgueux, 24000, France

Location

Related 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. 2012 Apr;99(4):558-65. doi: 10.1002/bjs.8724. No abstract available.

    PMID: 22396054RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Pr Serge Evrard
Organization
Digestive Tumours Unit, Institut Bergonie
s.evrard@brdeaux.unicancer.fr

Study Officials

  • Serge EVRARD, Pr

    Institut Bergonié

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

June 1, 2003

Primary Completion

December 1, 2008

Study Completion

May 1, 2010

Last Updated

May 18, 2021

Results First Posted

May 18, 2021

Record last verified: 2021-04

Locations

FR(12)