- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00807300
Computed Tomography (CT) - Guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma (CEAL)
Phase-III-Study to Evaluate the Efficacy of CT-guided Brachytherapy Versus Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Saxony-anhalt
-
Magdeburg, Saxony-anhalt, Germany, 39120
- Clinic of Diagnostic Radiology and Nuclear Medicine, Medical Faculty, University Magdeburg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: brachytherapy
|
catheter placed into the tumor by CT-guidance, radiation with iridium 192
|
Other: TACE
transarterial chemoembolization
|
application of doxorubicin and cisplatin in lipiodol into the tumor-feeding artery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to untreatable progression
Time Frame: the follow up period
|
the follow up period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to progression
Time Frame: the follow up period
|
the follow up period
|
Overall survival
Time Frame: the follow up period
|
the follow up period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jens Ricke, M.D., Clinic of Diagnostic Radiology and Nuclear Medicine, University Magdeburg
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-000569-21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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