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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 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: June 6, 2014
Last verified: June 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 2

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
  • Prior Chemotherapy
  • 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
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 6, 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 July 28, 2014