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

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: transarterial chemoembolization; Radiation: CT-guided brachytherapy

• Registration Number: NCT00807300
• Lead Sponsor: University of Magdeburg

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-II study to evaluate the efficacy and survival-benefits of brachytherapy versus transarterial chemoembolization in patients with unresectable HCC.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2008-12-10
• Study First Posted: 2008-12-11
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TACE	transarterial chemoembolization	transarterial chemoembolization
brachytherapy	CT-guided brachytherapy	-

Primary Outcome Measures

Name	Time	Method
Time to untreatable progression	the follow up period

Secondary Outcome Measures

Name	Time	Method
Time to progression	the follow up period
Overall survival	the follow up period

Trial Locations

Locations (1)

Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg; 🇩🇪 Magdeburg, Saxony-anhalt, Germany