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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Magdeburg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Magdeburg
ClinicalTrials.gov Identifier:
NCT00807300
First received: December 9, 2008
Last updated: August 3, 2010
Last verified: August 2010
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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.

Resource links provided by NLM:


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: October 2010 (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
TACE
transarterial chemoembolization
Procedure: transarterial chemoembolization
application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00807300

Contacts
Contact: Konrad Mohnike, M.D. 0049-391-67-15787 konrad.mohnike@med.ovgu.de
Contact: Jens Ricke, M.D. 0049-391-67-13030 jens.ricke@med.ovgu.de

Locations
Germany
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    Konrad.Mohnike@med.ovgu.de   
Contact: Jens Ricke, M.D.    0049-391-67-13030    jens.ricke@med.ovgu.de   
Principal Investigator: jens ricke, M.D.         
Sponsors and Collaborators
University of Magdeburg
Investigators
Principal Investigator: Jens Ricke, M.D. Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Jens Ricke, Clinic of Radiology and Nuclear Medicine, University of Magdeburg
ClinicalTrials.gov Identifier: NCT00807300     History of Changes
Other Study ID Numbers: 2005-000569-21
Study First Received: December 9, 2008
Last Updated: August 3, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Magdeburg:
percutaneous treatment

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 23, 2014