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

Hepatocellular Carcinoma Clinical Trial

— CEAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807300
• Other study ID #: 2005-000569-21
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2008
• Last updated: December 2, 2015
• Start date: October 2006
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
Germany	Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg	Magdeburg	Saxony-anhalt

Sponsors (1)

Lead Sponsor	Collaborator
University of Magdeburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to untreatable progression		the follow up period	No
Secondary	Time to progression		the follow up period	No
Secondary	Overall survival		the follow up period	No