Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation

Phase 2

Completed

• Conditions: Primary Liver Cancer
• Interventions: Device: Transarterialchemoembolisation (TACE); Device: DC Bead with Doxorubicin

• 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

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-12-01
• Study First Submitted QC: 2005-12-01
• Study First Posted: 2005-12-05
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-21

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

Arm && Interventions

Group	Intervention	Description
Transarterialchemoembolisation (TACE)	Transarterialchemoembolisation (TACE)	Conventional TACE with doxorubicin
DC Bead	DC Bead with Doxorubicin	DC Bead with doxorubicin

Primary Outcome Measures

Name	Time	Method
Objective response rate measured according to RECIST and EASL	6 months

Secondary Outcome Measures

Name	Time	Method
Change in Alpha Fetal Protein (AFP) over time	6 months
Health care resource use	6 months
Other procedures or interventions required	6 months
Local Tumour Response	6 months
Patient quality of life	6 months
Safety	6 months
Toxicity	6 month
Time to hospital discharge	6 months
Cardiotoxicity	6 months
Time To Progression	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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