Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma

NCT ID: NCT01489410

Last Updated: 2017-08-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-03-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Drug-Eluting Beads (DEB) with Doxorubicin

Intervention Type: DRUG

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).

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.

Group Type: ACTIVE_COMPARATOR

Lipiodol Ethanol Mixture

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Doxorubicin; LEM

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Cressman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

2011LS117

Identifier Type: -

Identifier Source: org_study_id