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

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

This study is currently recruiting participants.
Verified by Institut Bergonié, October 2007

Sponsored by:	Institut Bergonié
Information provided by:	Institut Bergonié
ClinicalTrials.gov Identifier:	NCT00210106

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 II

MedlinePlus related topics:

Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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
Estimated Study Completion Date:	January 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210106

Contacts


Contact: Serge EVRARD, Pr	00 33 0556333266	evrard@bergonie.org

Contact: Simone MATHOULIN-PELISSIER, MD, PhD	0033 05 56 33 33 98	mathoulin@bergonie.org

Locations


France
	Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest	Recruiting
	Bordeaux, France, 33076
	Contact: Serge EVRARD, Pr evrard@bergonie.org
	Principal Investigator: Serge EVRARD, Pr
	CHU de Bordeaux	Recruiting
	Bordeaux, France, 33076
	CHU d'Angers	Recruiting
	Angers, France, 49000
	Hopital Saint Eloi	Recruiting
	Montpellier, France, 34000
	Hopital de la Croix Rousse	Recruiting
	Lyon, France, 69000
	Centre Saint Michel	Recruiting
	Angoulême, France, 16000
	Clinique Francheville	Recruiting
	Périgueux, France, 24000
	Hopital Sub-Urbain du Bouscat	Recruiting
	Le Bouscat, France, 33110
	Clinique Mutualiste de Pessac	Recruiting
	Pessac, France, 33600
	Centre de Radiothérapie et d'Oncologie Médicale	Recruiting
	Pau, France, 64000
	Centre Hospitalier	Not yet recruiting
	Niort, France, 79000
	Hopital Béclère	Recruiting
	Clamart, France, 92140

Sponsors and Collaborators

Institut Bergonié

Investigators


Principal Investigator:	Serge EVRARD, Pr	Institut Bergonié

More Information

Study ID Numbers:	IB2003-11, ARF2003
First Received:	September 12, 2005
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00210106
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Bergonié:

Radiofrequency ablation

Colorectal cancer

Liver metastases

Study placed in the following topic categories:

Digestive System Diseases

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Neoplasm Metastasis

Gastrointestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Intestinal Neoplasms

Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplastic Processes

Neoplasms

Pathologic Processes

Neoplasms by Site

ClinicalTrials.gov processed this record on October 03, 2008