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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| brachytherapy | Active Comparator |
| |
| TACE | Other | transarterial chemoembolization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-guided brachytherapy | Radiation | catheter placed into the tumor by CT-guidance, radiation with iridium 192 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to untreatable progression | the follow up period |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | the follow up period | |
| Overall survival | the follow up period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Ricke, M.D. | Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg | Magdeburg | Saxony-Anhalt | 39120 | Germany |
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| transarterial chemoembolization | Procedure | application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery |
|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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