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Efficacy of CT-Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma (HCC) (AL vs TACE)
This study is currently recruiting participants.
Verified by University of Magdeburg, December 2008
Sponsored by: University of Magdeburg
Information provided by: University of Magdeburg Identifier: NCT00807300

Percutaneous, image-guided tumor ablation has evolved as a genuine alternative for the treatment of unresectable hepatocellular carcinoma. Published data exploring stereotactic or proton beam percutaneous irradiation have revealed,that hepatocellular carcinoma (HCC) is radiosensitive to certain protocols. In Phase I and II studies, the investigators investigated the potential role of local irradiation in primary and secondary liver tumors employing a Iridium192 source .The promising results of previous studies indicate that CT-guided brachytherapy might play a role in the treatment of unresectable HCC.

Therefore, the investigators started a randomized, controlled, clinical Phase-III-study to evaluate the efficacy and survival-benefits of brachytherapy versus transarterial chemoembolization in patients with unresectable HCC.

Condition Intervention Phase
Hepatocellular Carcinoma
Radiation: CT-guided brachytherapy
Procedure: transarterial chemoembolization
Phase III

MedlinePlus related topics: Cancer
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cisplatin Lipiodol Ethiodized oil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title: Phase-III-Study to Evaluate the Efficacy of CT-Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma.

Further study details as provided by University of Magdeburg:

Primary Outcome Measures:
  • Time to progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: October 2006
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
brachytherapy: Active Comparator Radiation: CT-guided brachytherapy
catheter placed into the tumor by CT-guidance, radiation with iridium 192
transarterial chemoembolization
Procedure: transarterial chemoembolization
application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00807300

Contact: Konrad Mohnike, M.D. 0049-391-67-15787
Contact: Jens Ricke, M.D. 0049-391-67-13030

Germany, Saxony-Anhalt
Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg Recruiting
Magdeburg, Saxony-Anhalt, Germany, 39120
Contact: Konrad Mohnike, M.D.     0049-391-67-15787    
Contact: Jens Ricke, M.D.     0049-391-67-13030    
Principal Investigator: jens ricke, M.D.            
Sponsors and Collaborators
University of Magdeburg
Principal Investigator: Jens Ricke, M.D. Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg
  More Information

Responsible Party: Clinic of Radiology and Nuclear Medicine, University of Magdeburg ( Prof. Dr. med. Jens Ricke )
Study ID Numbers: 2005-000569-21
Study First Received: December 9, 2008
Last Updated: December 10, 2008 Identifier: NCT00807300  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Magdeburg:
percutaneous treatment

Study placed in the following topic categories:
Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Liver Neoplasms
Digestive System Diseases
Ethiodized Oil
Gastrointestinal Neoplasms
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:
Neoplasms by Site
Neoplasms by Histologic Type processed this record on January 13, 2009