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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807300
First Posted: December 11, 2008
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jens Ricke, University of Magdeburg
  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-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: None (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
TACE
transarterial chemoembolization
Procedure: transarterial chemoembolization
application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807300


Locations
Germany
Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg
Magdeburg, Saxony-anhalt, Germany, 39120
Sponsors and Collaborators
University of Magdeburg
Investigators
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
ClinicalTrials.gov Identifier: NCT00807300     History of Changes
Other Study ID Numbers: 2005-000569-21
First Submitted: December 9, 2008
First Posted: December 11, 2008
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Jens Ricke, 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