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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 March 2015
Main ID:  NCT00210106
Date of registration: 12/09/2005
Prospective Registration: No
Primary sponsor: Institut BergoniƩ
Public title: Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy. ARF2003
Scientific title: Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy. A Phase 2 Study.
Date of first enrolment: June 2003
Target sample size: 53
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00210106
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
France
Contacts
Name:     Serge EVRARD, Pr
Address: 
Telephone:
Email:
Affiliation:  Institut BergoniĆ©
Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

-



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Colorectal Cancer
Intervention(s)
Device: Ablathermy
Primary Outcome(s)
Liver recurrence rate at 3 months after treatment
Secondary Outcome(s)
- Morbidity of radiofrequency ablation
- overall survival at 1 year
- Quality of live
- Disease free Survival 1 year
Secondary ID(s)
IB2003-11
ARF2003
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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