Computed Tomography (CT) - Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma (CEAL)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Magdeburg.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Magdeburg
Information provided by:
University of Magdeburg
ClinicalTrials.gov Identifier:
NCT00807300
First received: December 9, 2008
Last updated: August 3, 2010
Last verified: August 2010
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Purpose
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 |
|---|---|---|
|
Hepatocellular Carcinoma |
Radiation: CT-guided brachytherapy Procedure: transarterial chemoembolization |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase-III-Study to Evaluate the Efficacy of CT-guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma. |
Resource links provided by NLM:
Further study details as provided by University of Magdeburg:
Primary Outcome Measures:
- Time to progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 68 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: brachytherapy |
Radiation: CT-guided brachytherapy
catheter placed into the tumor by CT-guidance, radiation with iridium 192
|
|
TACE
transarterial chemoembolization
|
Procedure: transarterial chemoembolization
application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807300
Contacts
| 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 |
Locations
| Germany | |
| 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. | |
Sponsors and Collaborators
University of Magdeburg
Investigators
| Principal Investigator: | Jens Ricke, M.D. | Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg |
More Information
No publications provided
| Responsible Party: | Prof. Dr. med. Jens Ricke, Clinic of Radiology and Nuclear Medicine, University of Magdeburg |
| ClinicalTrials.gov Identifier: | NCT00807300 History of Changes |
| Other Study ID Numbers: | 2005-000569-21 |
| Study First Received: | December 9, 2008 |
| Last Updated: | August 3, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Magdeburg:
|
percutaneous treatment |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 23, 2013