Back to resultsComparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Drug-Eluting Beads (DEB) with Doxorubicin
Lipiodol Ethanol Mixture
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Child-Pugh class A or B
- Biopsy proven HCC or hypervascular mass per European Association for the Study of the Liver (EASL) criteria
- Patient not a candidate for surgical resection or percutaneous ablation
- age > 18 years old and able to consent
Exclusion Criteria:
- Child-Pugh class C
- Model for End-Stage Liver Disease (MELD) score >16
- Extrahepatic disease
- Bilateral or main portal vein thrombus
- Total bilirubin > 2.2
- Serum albumin < 2.6
- Life expectancy < 2 months
- Uncorrected INR > 2
- Eastern Cooperative Oncology Group (ECOG) status > 2
- Tumor burden > 50% liver volume
- Hepatofugal portal venous flow
Sites / Locations
- Masonic Cancer Center, University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Drug-Eluting Beads with Doxorubicin
Lipiodol Ethanol Mixture (LEM)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of Patients with Post-Embolization Syndrome
Count of patients with post-embolizaation syndrome reported which includes fatigue, anorexia, nausea, fever.
Secondary Outcome Measures
Patients with Encephalopathy After Embolization
Count of patients who had encephalopathy after embolization.
Changes in Quality of Life
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
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
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
Overall Survival
Determined by date of death or date censored.
Full Information
NCT ID
NCT01489410
First Posted
December 6, 2011
Last Updated
August 30, 2017
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01489410
Brief Title
Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma
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 Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient staff
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chemoembolization of hepatocellular carcinoma lesions is an accepted and frequently used method for the palliative or curative treatment of these lesions. These attempts are being made to make these patients a better candidate for liver transplant or to provide palliation for their condition.
Detailed Description
This is a randomized prospective study with two arms, Drug-Eluting Beads with doxorubicin (DEB) and lipiodol ethanol mixture (LEM), with the goal to show non-inferiority of LEM, which if true will facilitate a simple alternative to DEBs. Patients will be randomized to one arm of the study and will remain in that arm if they need to have more embolization in the future. Both of the mentioned methods (DEB and LEM) fall within the standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug-Eluting Beads with Doxorubicin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lipiodol Ethanol Mixture (LEM)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Drug-Eluting Beads (DEB) with Doxorubicin
Other Intervention Name(s)
Doxorubicin
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Lipiodol Ethanol Mixture
Other Intervention Name(s)
LEM
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Patients with Post-Embolization Syndrome
Description
Count of patients with post-embolizaation syndrome reported which includes fatigue, anorexia, nausea, fever.
Time Frame
Week 6 Post Intervention
Secondary Outcome Measure Information:
Title
Patients with Encephalopathy After Embolization
Description
Count of patients who had encephalopathy after embolization.
Time Frame
Week 6 Post Intervention
Title
Changes in Quality of Life
Description
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).
Time Frame
Baseline and Week 6 After Intervention
Title
Comparison of Liver Function Tests Results
Description
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.
Time Frame
Day 0 and Week 6 Post Intervention
Title
Imaging Response
Description
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.
Time Frame
Week 6 Post Intervention
Title
Number of Patients with Successful Liver Transplant
Time Frame
Week 6 After Intervention
Title
Overall Survival
Description
Determined by date of death or date censored.
Time Frame
Week 6 After Intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Child-Pugh class A or B
Biopsy proven HCC or hypervascular mass per European Association for the Study of the Liver (EASL) criteria
Patient not a candidate for surgical resection or percutaneous ablation
age > 18 years old and able to consent
Exclusion Criteria:
Child-Pugh class C
Model for End-Stage Liver Disease (MELD) score >16
Extrahepatic disease
Bilateral or main portal vein thrombus
Total bilirubin > 2.2
Serum albumin < 2.6
Life expectancy < 2 months
Uncorrected INR > 2
Eastern Cooperative Oncology Group (ECOG) status > 2
Tumor burden > 50% liver volume
Hepatofugal portal venous flow
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Cressman, M.D.
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma
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