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Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).

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ClinicalTrials.gov Identifier: NCT01798160
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):
Michael Bernhard Pitton, Johannes Gutenberg University Mainz

Tracking Information
First Submitted Date  ICMJE February 16, 2013
First Posted Date  ICMJE February 25, 2013
Last Update Posted Date October 20, 2015
Study Start Date  ICMJE February 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
  • Progression-free-Survival [ Time Frame: up to three years ]
  • Overall-Survival [ Time Frame: up to three years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).
Official Title  ICMJE Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).
Brief Summary Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • Procedure: DEB TACE
    DEB TACE every 6 weeks until either no viable tumor or endpoint reached.
    Other Name: Chemoembolization
  • Procedure: SIRT
    Selective Internal Radiation Therapy once at the beginning of the study. Follow up until endpoint.
    Other Name: Radioembolization
Study Arms  ICMJE
  • Active Comparator: DEB TACE
    Drug eluting Beads (DC Beads) loaded with Doxorubicin
    Intervention: Procedure: DEB TACE
  • Experimental: SIRT
    Selective Internal Radiation Therapy using Yttrium 90 loaded resin beads (Sir Spheres)
    Intervention: Procedure: SIRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 21, 2013)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥18 years
  • HCC, proven by histology or according to EASL criteria
  • Intermediate stage HCC (stage B according to BCLC)
  • At least one measurable lesion in magnetic resonance imaging (MRI)
  • Tumor load ≤ 50%
  • preserved liver function (Child Pugh A and B)

Exclusion Criteria:

  • Patients feasible for curative treatment (e.g. resection or local ablation)
  • Previous TACE or SIRT
  • Chemotherapy during the last 4 weeks
  • Child Pugh stage C
  • BCLC stage D
  • ECOG Performance Status >0
  • Tumor involvement >50% of the liver
  • Extrahepatic tumor
  • Serum Bilirubin >2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine >2 mg/dl; Leukocytes <3000/ml; Thrombocytes <50000/ml
  • Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
  • Esophageal bleeding during the last 3 months
  • Hepatic encephalopathy
  • Transjugular intrahepatic portosystemic shunt (TIPS)
  • Infiltration or occlusion of the portal vein
  • Hepatofugal blood flow in the portal vein
  • Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan
  • Contraindications against angiography
  • Gravidity
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01798160
Other Study ID Numbers  ICMJE SIRT-TACE-HCC-Mainz-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Bernhard Pitton, Johannes Gutenberg University Mainz
Study Sponsor  ICMJE Johannes Gutenberg University Mainz
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Johannes Gutenberg University Mainz
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP