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:
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210106
First received: September 12, 2005
Last updated: December 29, 2011
Last verified: October 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


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
Estimated Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00210106     History of Changes
Other Study ID Numbers: IB2003-11, ARF2003
Study First Received: September 12, 2005
Last Updated: December 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on October 20, 2014