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

NCT ID: NCT00210106

Last Updated: 2021-05-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2010-05-31

Brief Summary

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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

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intraoperative radiofrequency ablation (IRFA)

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.

Group Type EXPERIMENTAL

Ablathermy

Intervention Type DEVICE

Interventions

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Ablathermy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Bergonié

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Serge EVRARD, Pr

Role: PRINCIPAL_INVESTIGATOR

Institut Bergonié

Locations

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CHU d'Angers

Angers, , France

Site Status

Centre Saint Michel

Angoulême, , France

Site Status

CHU de Bordeaux

Bordeaux, , France

Site Status

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

Bordeaux, , France

Site Status

Hopital Béclère

Clamart, , France

Site Status

Hopital Sub-Urbain du Bouscat

Le Bouscat, , France

Site Status

Hopital de la Croix Rousse

Lyon, , France

Site Status

Hopital Saint Eloi

Montpellier, , France

Site Status

Centre Hospitalier

Niort, , France

Site Status

Centre de Radiothérapie et d'Oncologie Médicale

Pau, , France

Site Status

Clinique Mutualiste de Pessac

Pessac, , France

Site Status

Clinique Francheville

Périgueux, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 22396054 (View on PubMed)

Other Identifiers

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ARF2003

Identifier Type: -

Identifier Source: secondary_id

IB2003-11

Identifier Type: -

Identifier Source: org_study_id

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