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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00807300

Acronym

CEAL

Enrollment

Registered

2008-12-11

Start date

2006-10-31

Completion date

2015-12-31

Last updated

2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

percutaneous treatment

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.

Interventions

RADIATIONCT-guided brachytherapy

catheter placed into the tumor by CT-guidance, radiation with iridium 192

PROCEDUREtransarterial chemoembolization

application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Time to untreatable progression	the follow up period

Secondary

Measure	Time frame
Time to progression	the follow up period
Overall survival	the follow up period

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026