Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).
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|ClinicalTrials.gov Identifier: NCT01798160|
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : October 20, 2015
Johannes Gutenberg University Mainz
Information provided by (Responsible Party):
Michael Bernhard Pitton, Johannes Gutenberg University Mainz
Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Procedure: DEB TACE Procedure: SIRT||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Active Comparator: DEB TACE
Drug eluting Beads (DC Beads) loaded with Doxorubicin
Procedure: DEB TACE
DEB TACE every 6 weeks until either no viable tumor or endpoint reached.
Other Name: Chemoembolization
Selective Internal Radiation Therapy using Yttrium 90 loaded resin beads (Sir Spheres)
Selective Internal Radiation Therapy once at the beginning of the study. Follow up until endpoint.
Other Name: Radioembolization
Primary Outcome Measures :
- Progression-free-Survival [ Time Frame: up to three years ]
- Overall-Survival [ Time Frame: up to three years ]
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