Efficacy of CT-Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma (HCC) - Full Text View

Sponsored by:	University of Magdeburg
Information provided by:	University of Magdeburg
ClinicalTrials.gov Identifier:	NCT00807300

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 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
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, 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 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

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
ClinicalTrials.gov 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
Doxorubicin
Carcinoma
Liver Neoplasms

Digestive System Diseases
Cisplatin
Ethiodized Oil
Gastrointestinal Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009