Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma (MIRACLE I)

August 24, 2016 updated by: Boston Scientific Corporation
This is a non-randomized, prospective, pilot, Multicenter Study of Drug-eluting bead transarterial chemoembolization (DEB-TACE) using Doxorubicin-Loaded Embozene® Tandem™ Microspheres to treat hepatocellular carcinoma (HCC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Regensburg, Germany, 93042
        • University Hospital Regensburg
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • Klinikum der Universität Heidelberg
      • Heilbronn, Baden-Wuerttemberg, Germany, 74078
        • SLK-Kliniken Heilbronn GmbH
      • Stuttgart, Baden-Wuerttemberg, Germany, 70174
        • Klinikum Stuttgart- Katharinenhospital
    • Bayern
      • Munchen, Bayern, Germany, 81925
        • Klinikum Bogenhausen
    • Hessen
      • Darmstadt, Hessen, Germany, 64283
        • Kilinikum Darmstadt
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • Universitätsklinikum Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with a confirmed diagnosis of HCC according to the European Association for the Study of the Liver (EASL) criteria for diagnosis, and staged according to the Barcelona clinic liver cancer (BCLC) criteria
  2. Subject is competent and willing to provide written informed consent in order to participate in the study
  3. Adults (male or female) patients ≥ 18 years of age
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Child Pugh classification is 0-11
  5. Multidonar or single nodular tumor ≥3-10cm, Patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3-5 weeks. Patient must have at least one tumor lesion that meets the following criteria: Lesion can be accurately measured in at least one dimension according to modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria
  6. No invasion in the major blood vessel (hepatic portal, hepatic vein) or bile duct by the Magnetic resonance imaging (MRI) or Computed Tomography (CT)
  7. Proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study
  8. No current infections requiring antibiotic therapy
  9. Not actively on cumarin based anticoagulation or suffering from a known bleeding disorder
  10. Measurable disease per the Response Evaluation Criteria in Solid Tumors (mRECIST)
  11. Expected survival more than 6 months

Exclusion Criteria:

  1. ECOG performance status >2; or Child-Pugh class C11 or more, or ASA class 5
  2. Bilirubin levels >3 mg/dl
  3. HCC with large vessel or biliary duct invasion, diffuse HCC or extrahepatic spread

  4. Patients in which any of the following are contraindicated or present:

    • The use of doxorubicin
    • MRI
    • Hepatic embolization procedures
    • White blood cell (WBC) < 3000 cells/mm3
    • neutrophil < 1500 cells/mm3
    • Cardiac ejection fraction < 50 percent assessed by isotopic ventriculography, echocardiography or MR
    • Elevated creatinine greater than or equal to 2.5 mg/dl
    • Impaired clotting test (platelet count < 5 x 104/mm3, Prothrombin time-International normalized ratio (PT-INR > 2.0)
    • aspartate transaminase (AST) and/or alanine transaminase (ALT) >5x ULN or, when greater >250 U/L
    • Known hepatofugal blood flow
    • Arterio-venous shunt
    • Arterio-portal shunt
    • Main stem portal vein occlusion(point 6 in inclusion criteria)
  5. Women who are pregnant or breast feeding
  6. Allergy to iodinated contrast used for angiography
  7. Tumour burden of more than 50% of liver
  8. Patients with objective signs of active bacterial, viral (human immunodeficiency virus (HIV)), or fungal infection
  9. Other primary malignancies or evidence of metastatic disease
  10. Patients previously treated with anthracyclines (other than doxorubicin).
  11. Any co-morbid disease or condition or event that, in the investigator's judgment, would place the patient at undue risk that would preclude the safe use of DEB-TACE.
  12. Under no circumstances should patients be enrolled in this study who is already participating in another study for treatment of primary liver cancer.
  13. Under no circumstances should patients be enrolled in this study who has received any other embolotherapy (including Selective Internal Radiation Therapy (SIRT)) for the treatment of primary liver cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: DEB-TACE

Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)

Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin
Device: TANDEM™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Serious Adverse Event (SAE) at 30days
Time Frame: Up to 30 days
Up to 30 days
Freedom From Study Related SAE at 6 Months
Time Frame: Up to 6 months
Up to 6 months
Freedom From Tumor Progression at 6 Months
Time Frame: 6 months
Progression was assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST - Lencioni and Llovet 2010) as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
12 Month Survival
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Gotz M Richter, MD, Klinikum Stuttgart - Katharinenhospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

December 6, 2012

First Submitted That Met QC Criteria

February 22, 2013

First Posted (ESTIMATE)

February 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TANDEM 2012-001 OUS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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