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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISION V)

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 Summary:
Sponsor: Biocompatibles UK Ltd

Current Primary Outcome: Objective response rate measured according to RECIST and EASL [ Time Frame: 6 months ]

Original Primary Outcome: Objective response rate measured according to RECIST and EASL

Current Secondary Outcome:

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


Original Secondary Outcome:

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


Information By: Biocompatibles UK Ltd

Dates:
Date Received: December 1, 2005
Date Started: November 2005
Date Completion:
Last Updated: June 14, 2010
Last Verified: June 2010