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