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Computed Tomography (CT) - Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma (CEAL)

This study has been completed.
Information provided by (Responsible Party):
Jens Ricke, University of Magdeburg Identifier:
First received: December 9, 2008
Last updated: December 2, 2015
Last verified: December 2015

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-II 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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Jens Ricke, University of Magdeburg:

Primary Outcome Measures:
  • Time to untreatable progression [ Time Frame: the follow up period ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: the follow up period ]
  • Overall survival [ Time Frame: the follow up period ]

Enrollment: 77
Study Start Date: October 2006
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: brachytherapy 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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00807300

Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg
Magdeburg, Saxony-anhalt, Germany, 39120
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: Jens Ricke, Prof. Jens Ricke, University of Magdeburg Identifier: NCT00807300     History of Changes
Other Study ID Numbers: 2005-000569-21
Study First Received: December 9, 2008
Last Updated: December 2, 2015

Keywords provided by Jens Ricke, University of Magdeburg:
percutaneous treatment

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on May 25, 2017