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

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

Phase-III-Study to Evaluate the Efficacy of CT-Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma.

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Primary Outcome Measure ^†

Time to progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Condition ^†

Hepatocellular Carcinoma

Intervention ^†

Radiation: CT-guided brachytherapy
Procedure: transarterial chemoembolization

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

October 2006

Completion Date

October 2011

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

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

Location Countries ^†

Germany

Administrative Information Fields

NCT ID ^†

NCT00807300

Organization ID

2005-000569-21

Secondary IDs ^††

Study Sponsor ^†

University of Magdeburg

Collaborators ^††

Investigators ^†

Principal Investigator:

Jens Ricke, M.D.

Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg

Information Provided By

University of Magdeburg

Verification Date

December 2008

First Received Date ^†

December 9, 2008

Last Updated Date

December 10, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.