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Sponsored by: |
Biocompatibles UK Ltd |
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Information provided by: | Biocompatibles UK Ltd |
ClinicalTrials.gov Identifier: | NCT00261378 |
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
Condition | Intervention | Phase |
---|---|---|
Primary Liver Cancer |
Device: Transarterialchemoembolisation (TACE) |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind, Active Control, Parallel Assignment |
Official Title: | Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISION V) |
Study Start Date: | November 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Advanced liver disease:
Advanced tumoural disease:
Any contraindication for doxorubicin administration:
Any contraindication for hepatic embolisation procedures:
Austria | |
Allgemines Krankenhaus Vienna | |
Vienna, Austria, 1090 | |
Medizinische Universitat Innsbruck | |
Innsbruck, Austria, 6020 | |
France | |
L'Hopital Beaujon | |
Clichy, France, 92100 | |
Groupement Hospitalier Edouard Herriot | |
Lyon, France, 69437 | |
Hopital Pitie Salpetriere | |
Paris, France, 75013 | |
Hopital Archet II | |
Nice, France, 6200 | |
CHU Rangueil | |
Toulouse, France, 31059 | |
Hopital Claude Huriez | |
Lille, France, 59037 | |
Institut Gustave Roussy | |
Villejuif, France, 94805 | |
Germany | |
Medicinische Hochschule Hannover | |
Hannover, Germany, 30625 | |
Klinikum der Johannes Guttenberg | |
Mainz, Germany, 55131 | |
Fakultat fur Klinische Medizin Mannheim Universitat | |
Mannheim, Germany, 68167 | |
Klinikum der Johann-Wolfgang-Goethe-Universitat | |
Frankfurt am Main, Germany, 60590 | |
Switzerland | |
Universitatsspital Zurich | |
Zurich, Switzerland, 8091 | |
Inselspital Bern | |
Bern, Switzerland, 3010 | |
Hopitaux Universitaires de Geneve | |
Geneve, Switzerland, 3010 | |
Centre Hospitalier Universitaire Vaudois | |
Lausanne, Switzerland, 1011 |
Principal Investigator: | Prof Johannes Lammer | The Allgemines Krankenhaus, Vienna, 1090, Austria |
Study ID Numbers: | CA1008 |
Study First Received: | December 1, 2005 |
Last Updated: | July 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00261378 |
Health Authority: | Austria: Federal Ministry for Social Security and Generations, Vienna, Austria; Germany: Ethics Commission; France: Afssaps - French Health Products Safety Agency |
Hepatocellular Carcinoma (HCC) |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms |
Gastrointestinal Neoplasms Adenocarcinoma Doxorubicin Hepatocellular carcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |