Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma
|ClinicalTrials.gov Identifier: NCT01489410|
Recruitment Status : Withdrawn (Insufficient staff)
First Posted : December 9, 2011
Last Update Posted : August 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Drug-Eluting Beads (DEB) with Doxorubicin Drug: Lipiodol Ethanol Mixture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Study Comparing Lipiodol Plus Ethanol Solution Compared With Drug-Eluting Beads for Trans-arterial Chemoembolization of Liver in Treatment of Hepatocellular Carcinoma|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Active Comparator: Drug-Eluting Beads with Doxorubicin
Drug-Eluting Beads (DEB) with Doxorubicin is administered via beads that release it to the liver through a groin puncture site and delivered via catheter through the vessels that feed the liver.
Drug: Drug-Eluting Beads (DEB) with Doxorubicin
One treatment of Drug-Eluting Beads (DEB) with Doxorubicin administered to the liver through a groin puncture site and delivered through the vessels that feed the liver (per standard of care).
Other Name: Doxorubicin
Active Comparator: Lipiodol Ethanol Mixture (LEM)
Lipiodol Ethanol Mixture (LEM) is administered to the liver through a groin puncture site and delivered via catheter through the vessels that feed the liver.
Drug: Lipiodol Ethanol Mixture
One treatment of Lipiodol Ethanol Mixture (LEM) is administered to the liver through a groin puncture site and delivered through the vessels that feed the liver (per standard of care).
Other Name: LEM
- Number of Patients with Post-Embolization Syndrome [ Time Frame: Week 6 Post Intervention ]Count of patients with post-embolizaation syndrome reported which includes fatigue, anorexia, nausea, fever.
- Patients with Encephalopathy After Embolization [ Time Frame: Week 6 Post Intervention ]Count of patients who had encephalopathy after embolization.
- Changes in Quality of Life [ Time Frame: Baseline and Week 6 After Intervention ]Changes (noted as a score of 0 [not at all] to 4 [very much]; total score ranges from 1-180) in the different aspects of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) quality of life questionnaire (a 45-item self-report instrument designed to measure health-related quality of life in patients with hepatobiliary cancers).
- Comparison of Liver Function Tests Results [ Time Frame: Day 0 and Week 6 Post Intervention ]List of results for alpha-fetoprotein (AFP), albumin (Alb), alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALKP), blood urea nitrogen (BUN), creatinine (Cr), glomerular filtration rate (GFR), Bilirubin (T, D), platelets (Plt), international normalized ratio (INR - prothrombin time), Child-Pugh score.
- Imaging Response [ Time Frame: Week 6 Post Intervention ]Determined by European Association for the Study of the Liver (EASL) criteria a set of non-invasive criteria for HCC in cirrhotic patients. The diagnosis is established if two imaging modalities (US, CT, magnetic resonance imaging (MRI)) show a coincidental nodule with arterial hypervascularization regardless of AFP levels, or if a single modality shows a lesion when the AFP levels are more than 400 ng/ml. Histologic diagnosis is required if the patient is non-cirrhotic or if the lesions are smaller than 2 cm.
- Number of Patients with Successful Liver Transplant [ Time Frame: Week 6 After Intervention ]
- Overall Survival [ Time Frame: Week 6 After Intervention ]Determined by date of death or date censored.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489410
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Erik Cressman, M.D.||Masonic Cancer Center, University of Minnesota|