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:
Institut Bergonié
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210106
First received: September 12, 2005
Last updated: December 29, 2011
Last verified: October 2007
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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
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 | |
| Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest | |
| Bordeaux, France, 33076 | |
| CHU de Bordeaux | |
| 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 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 |
ClinicalTrials.gov processed this record on May 21, 2013