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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

Study Description
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Brief Summary:
Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: DEB TACE Procedure: SIRT Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).
Study Start Date : February 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: DEB TACE
Drug eluting Beads (DC Beads) loaded with Doxorubicin
 Procedure: DEB TACE
DEB TACE every 6 weeks until either no viable tumor or endpoint reached.
Other Name: Chemoembolization
Experimental: SIRT
Selective Internal Radiation Therapy using Yttrium 90 loaded resin beads (Sir Spheres)
 Procedure: SIRT
Selective Internal Radiation Therapy once at the beginning of the study. Follow up until endpoint.
Other Name: Radioembolization


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free-Survival [ Time Frame: up to three years ]
  2. Overall-Survival [ Time Frame: up to three years ]

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:

  • ≥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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Michael Bernhard Pitton, Consultant, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01798160    
Other Study ID Numbers: SIRT-TACE-HCC-Mainz-1
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
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