Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).

This study is currently recruiting participants.
Verified March 2014 by Johannes Gutenberg University Mainz
Sponsor:
Information provided by (Responsible Party):
Michael Bernhard Pitton, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01798147
First received: February 16, 2013
Last updated: March 1, 2014
Last verified: March 2014
  Purpose

Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).


Condition Intervention Phase
Intrahepatic Cholangiocellular Carcinoma
Procedure: DEB TACE
Procedure: SIRT
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: at the end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: at the end of study ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: at the end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: February 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Chemoembolisation
Experimental: SIRT
Selective Internal Radiotherapy using Yttrium 90 loaded resin beads (Sir Spheres)
Procedure: SIRT
Selective Internal Radiotherapy once at the beginning of the study. Follow up until endpoint.
Other Name: Radioembolisation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years
  • Intrahepatic CCC, proven by histology or by typical morphology in cross sectional imaging and elevated tumor markers (CEA or CA 19-9)
  • Tumor confined to the liver
  • At least one measurable lesion in magnetic resonance imaging (MRI)
  • Tumor load ≤ 50%
  • Preserved liver function (Child Pugh A and B)
  • ECOG performance status ≤2

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
  • ECOG Performance Status >1
  • 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 main portal vein
  • Hepatofugal blood flow in the portal vein
  • Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan (MAA-scan)
  • Contraindications against angiography
  • Gravidity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01798147

Contacts
Contact: Roman Kloeckner, MD ++49613117 ext 2019 roman.kloeckner@unimedizin-mainz.de

Locations
Germany
Department of Diagnostic and Interventional Radiology Recruiting
Mainz, Germany, 55131
Contact: Roman Kloeckner, MD    ++49613117 ext 2019    roman.kloeckner@unimedizin-mainz.de   
Sponsors and Collaborators
Johannes Gutenberg University Mainz
  More Information

No publications provided

Responsible Party: Michael Bernhard Pitton, Consultant, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01798147     History of Changes
Other Study ID Numbers: SIRT-TACE-CCC-Mainz-1
Study First Received: February 16, 2013
Last Updated: March 1, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:
Cholangiocellular Carcinoma
TACE
SIRT

Additional relevant MeSH terms:
Carcinoma
Cholangiocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma

ClinicalTrials.gov processed this record on April 17, 2014