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Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy. (ARF2003)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00210106
First Posted: September 21, 2005
Last Update Posted: March 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut Bergonié
  Purpose
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.

Condition Intervention Phase
Colorectal Cancer Device: Ablathermy Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy. A Phase 2 Study.

Further study details as provided by Institut Bergonié:

Primary Outcome Measures:
  • Liver recurrence rate at 3 months after treatment

Secondary Outcome Measures:
  • - overall survival at 1 year
  • - Disease free Survival 1 year
  • - Quality of live
  • - Morbidity of radiofrequency ablation

Estimated Enrollment: 53
Study Start Date: June 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210106


Locations
France
CHU d'Angers
Angers, France, 49000
Centre Saint Michel
Angoulême, France, 16000
CHU de Bordeaux
Bordeaux, France, 33076
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Hopital Béclère
Clamart, France, 92140
Hopital Sub-Urbain du Bouscat
Le Bouscat, France, 33110
Hopital de la Croix Rousse
Lyon, France, 69000
Hopital Saint Eloi
Montpellier, France, 34000
Centre Hospitalier
Niort, France, 79000
Centre de Radiothérapie et d'Oncologie Médicale
Pau, France, 64000
Clinique Mutualiste de Pessac
Pessac, France, 33600
Clinique Francheville
Périgueux, France, 24000
Sponsors and Collaborators
Institut Bergonié
Investigators
Principal Investigator: Serge EVRARD, Pr Institut Bergonié
  More Information

Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT00210106     History of Changes
Other Study ID Numbers: IB2003-11
ARF2003
First Submitted: September 12, 2005
First Posted: September 21, 2005
Last Update Posted: March 4, 2015
Last Verified: March 2015

Keywords provided by Institut Bergonié:
Radiofrequency ablation
Colorectal cancer
Liver metastases

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes