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Study 10 of 2219 for search of: | received on or after 11/14/2008 |
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Sponsored by: |
University of Magdeburg |
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Information provided by: | University of Magdeburg |
ClinicalTrials.gov Identifier: | NCT00807300 |
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-III-study to evaluate the efficacy and survival-benefits of brachytherapy versus transarterial chemoembolization in patients with unresectable HCC.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma |
Radiation: CT-guided brachytherapy Procedure: transarterial chemoembolization |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Phase-III-Study to Evaluate the Efficacy of CT-Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma. |
Estimated Enrollment: | 68 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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brachytherapy: Active Comparator |
Radiation: CT-guided brachytherapy
catheter placed into the tumor by CT-guidance, radiation with iridium 192
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TACE
transarterial chemoembolization
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Procedure: transarterial chemoembolization
application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Konrad Mohnike, M.D. | 0049-391-67-15787 | konrad.mohnike@med.ovgu.de |
Contact: Jens Ricke, M.D. | 0049-391-67-13030 | jens.ricke@med.ovgu.de |
Germany, Saxony-Anhalt | |
Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg | Recruiting |
Magdeburg, Saxony-Anhalt, Germany, 39120 | |
Contact: Konrad Mohnike, M.D. 0049-391-67-15787 Konrad.Mohnike@med.ovgu.de | |
Contact: Jens Ricke, M.D. 0049-391-67-13030 jens.ricke@med.ovgu.de | |
Principal Investigator: jens ricke, M.D. |
Principal Investigator: | Jens Ricke, M.D. | Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg |
Responsible Party: | Clinic of Radiology and Nuclear Medicine, University of Magdeburg ( Prof. Dr. med. Jens Ricke ) |
Study ID Numbers: | 2005-000569-21 |
Study First Received: | December 9, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00807300 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
percutaneous treatment |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Doxorubicin Carcinoma Liver Neoplasms |
Digestive System Diseases Cisplatin Ethiodized Oil Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |