Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation
Phase 2
Completed
- Conditions
- Primary Liver Cancer
- Registration Number
- NCT00261378
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The objective of this study is to assess the safety and efficacy of DC Bead™ delivered by intra-arterial embolisation for the treatment of Hepatocellular Carcinoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 212
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Objective response rate measured according to RECIST and EASL 6 months
- Secondary Outcome Measures
Name Time Method Health care resource use 6 months Safety 6 months Other procedures or interventions required 6 months Local Tumour Response 6 months Toxicity 6 month Time to hospital discharge 6 months Cardiotoxicity 6 months Time To Progression 6 months Change in Alpha Fetal Protein (AFP) over time 6 months Patient quality of life 6 months
Trial Locations
- Locations (17)
Medizinische Universitat Innsbruck
🇦🇹Innsbruck, Austria
Allgemines Krankenhaus Vienna
🇦🇹Vienna, Austria
L'Hopital Beaujon
🇫🇷Clichy, France
Hopital Claude Huriez
🇫🇷Lille, France
Groupement Hospitalier Edouard Herriot
🇫🇷Lyon, France
Hopital Archet II
🇫🇷Nice, France
Hopital Pitie Salpetriere
🇫🇷Paris, France
CHU Rangueil
🇫🇷Toulouse, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Klinikum der Johann-Wolfgang-Goethe-Universitat
🇩🇪Frankfurt am Main, Germany
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