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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: CT-guided brachytherapy
* Procedure: transarterial chemoembolization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: brachytherapy<br> | Radiation: CT-guided brachytherapy<br>* catheter placed into the tumor by CT-guidance, radiation with iridium 192<br>|
| Other: TACE<br>transarterial chemoembolization | Procedure: transarterial chemoembolization<br>* application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to untreatable progression |  | the follow up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | the follow up period | 
| Overall survival |  | the follow up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous treatment