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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798134
Recruitment Status : Completed
First Posted : February 25, 2013
Results First Posted : June 27, 2016
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Device: TANDEM™ Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy in Hepatocellular Carcinoma
Study Start Date : December 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : March 2015
Arms and Interventions
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Arm Intervention/treatment
DEB-TACE

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

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

 Device: TANDEM™


Outcome Measures
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Primary Outcome Measures :
  1. Freedom From Serious Adverse Event (SAE) at 30days [ Time Frame: Up to 30 days ]
  2. Freedom From Study Related SAE at 6 Months [ Time Frame: Up to 6 months ]
  3. 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.


Secondary Outcome Measures :
  1. 12 Month Survival [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798134


Locations
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Germany
Klinikum der Universitat Heidelberg
Heidelberg, Baden-Wuerttemberg, Germany, 69120
SLK-Kliniken Heilbronn GmbH
Heilbronn, Baden-Wuerttemberg, Germany, 74078
Klinikum Stuttgart- Katharinenhospital
Stuttgart, Baden-Wuerttemberg, Germany, 70174
Klinikum Bogenhausen
Munchen, Bayern, Germany, 81925
Kilinikum Darmstadt
Darmstadt, Hessen, Germany, 64283
Universitatsklinikum Essen
Essen, Nordrhein-Westfalen, Germany, 45147
University Hospital Regensburg
Regensburg, Germany, 93042
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Gotz M Richter, MD Klinikum Stuttgart - Katharinenhospital
More Information
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01798134    
Other Study ID Numbers: TANDEM 2012-001 OUS
First Posted: February 25, 2013    Key Record Dates
Results First Posted: June 27, 2016
Last Update Posted: October 3, 2016
Last Verified: August 2016
Keywords provided by Boston Scientific Corporation:
To show safety
and efficacy
investigational product
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases