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

University of Magdeburg

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: transarterial chemoembolization; Radiation: CT-guided brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00807300

2005-000569-21

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

brachytherapy

Active Comparator group

Treatment:

Radiation: CT-guided brachytherapy

TACE

Other group

Description:

transarterial chemoembolization

Treatment:

Procedure: transarterial chemoembolization