Phase-III-Study to Evaluate the Efficacy of CT-guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma.
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma
Both
Hepatocellular Carcinoma
Trial Information
Phase-III-Study to Evaluate the Efficacy of CT-guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma.
Inclusion Criteria:
- diagnosis of HCC by histopathology or according to the criteria of the Consensus
Conference of the European Association for the Study of Liver Disease
- unresectable HCC
- Karnofsky-Index > 70
- estimated life expectancy > 16 weeks
- adequate bone marrow function
- adequate contraception for female patients
- informed consent
Exclusion Criteria:
- portal vein thrombosis on the tumor side
- extrahepatic spread
- Child C
- other untreated malignant disease
- general contraindication for chemotherapy
- active infectious disease
- neuropathy, platin-allergy
- pregnancy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Jens Ricke, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
2005-000569-21
NCT ID:
NCT00807300
Start Date:
October 2006
Completion Date:
October 2011
Related Keywords:
- Hepatocellular Carcinoma
- percutaneous treatment
- Carcinoma
- Carcinoma, Hepatocellular
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