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

This study is currently recruiting participants.
Verified May 2017 by Michael Bernhard Pitton, Johannes Gutenberg University Mainz
Sponsor:
ClinicalTrials.gov Identifier:
NCT01798147
First Posted: February 25, 2013
Last Update Posted: May 23, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Bernhard Pitton, Johannes Gutenberg University Mainz
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).

Resource links provided by NLM:


Further study details as provided by Michael Bernhard Pitton, Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: at the end of study ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: at the end of study ]
  • Time to progression (TTP) [ Time Frame: at the end of study ]

Estimated Enrollment: 24
Study Start Date: February 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: February 16, 2013
First Posted: February 25, 2013
Last Update Posted: May 23, 2017
Last Verified: May 2017

Keywords provided by Michael Bernhard Pitton, Johannes Gutenberg University Mainz:
Cholangiocellular Carcinoma
TACE
SIRT

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