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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Masonic Cancer Center, University of Minnesota
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01489410
First received: December 6, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
Drug: Drug-Eluting Beads (DEB) with Doxorubicin
Drug: Lipiodol Ethanol Mixture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Number of Patients with Post-Embolization Syndrome [ Time Frame: Week 6 Post Intervention ] [ Designated as safety issue: Yes ]
    Count of patients with post-embolizaation syndrome reported which includes fatigue, anorexia, nausea, fever.


Secondary Outcome Measures:
  • Patients with Encephalopathy After Embolization [ Time Frame: Week 6 Post Intervention ] [ Designated as safety issue: Yes ]
    Count of patients who had encephalopathy after embolization.

  • Changes in Quality of Life [ Time Frame: Baseline and Week 6 After Intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Week 6 After Intervention ] [ Designated as safety issue: No ]
    Determined by date of death or date censored.


Estimated Enrollment: 238
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489410

Contacts
Contact: Erik Cressman, M.D. 612-626-5388 cress013@umn.edu

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Erik Cressman, M.D.    612-626-5388    cress013@umn.edu   
Principal Investigator: Erik Cressman, M.D.         
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Erik Cressman, M.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01489410     History of Changes
Other Study ID Numbers: 2011LS117
Study First Received: December 6, 2011
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Doxorubicin
Ethanol
Ethiodized Oil
Liposomal doxorubicin
Anti-Infective Agents
Anti-Infective Agents, Local
Antibiotics, Antineoplastic
Antineoplastic Agents
Central Nervous System Agents
Central Nervous System Depressants
Contrast Media
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014