NCT00807300

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: University of Magdeburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
RADIATION	CT-guided brachytherapy	catheter placed into the tumor by CT-guidance, radiation with iridium 192
PROCEDURE	transarterial chemoembolization	application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery

Timeline

• Start date: 2006-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2008-12-11
• Last updated: 2015-12-03

Locations

1 site across 1 country: Germany