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

Primary Purpose

Intrahepatic Cholangiocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
DEB TACE
SIRT
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrahepatic Cholangiocellular Carcinoma focused on measuring Cholangiocellular Carcinoma, TACE, SIRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Diagnostic and Interventional RadiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

DEB TACE

SIRT

Arm Description

Drug eluting Beads (DC Beads) loaded with Doxorubicin

Selective Internal Radiotherapy using Yttrium 90 loaded resin beads (Sir Spheres)

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

Overall survival (OS)
Time to progression (TTP)

Full Information

First Posted
February 16, 2013
Last Updated
May 21, 2017
Sponsor
Johannes Gutenberg University Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT01798147
Brief Title
Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).
Official Title
Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocellular Carcinoma
Keywords
Cholangiocellular Carcinoma, TACE, SIRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DEB TACE
Arm Type
Active Comparator
Arm Description
Drug eluting Beads (DC Beads) loaded with Doxorubicin
Arm Title
SIRT
Arm Type
Experimental
Arm Description
Selective Internal Radiotherapy using Yttrium 90 loaded resin beads (Sir Spheres)
Intervention Type
Procedure
Intervention Name(s)
DEB TACE
Other Intervention Name(s)
Chemoembolisation
Intervention Description
DEB TACE every 6 weeks until either no viable tumor or endpoint reached.
Intervention Type
Procedure
Intervention Name(s)
SIRT
Other Intervention Name(s)
Radioembolisation
Intervention Description
Selective Internal Radiotherapy once at the beginning of the study. Follow up until endpoint.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
at the end of study
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
at the end of study
Title
Time to progression (TTP)
Time Frame
at the end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roman Kloeckner, MD
Phone
++49613117
Ext
2019
Email
roman.kloeckner@unimedizin-mainz.de
Facility Information:
Facility Name
Department of Diagnostic and Interventional Radiology
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roman Kloeckner, MD
Phone
++49613117
Ext
2019
Email
roman.kloeckner@unimedizin-mainz.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
25095718
Citation
Kloeckner R, Ruckes C, Kronfeld K, Worns MA, Weinmann A, Galle PR, Lang H, Otto G, Eichhorn W, Schreckenberger M, Dueber C, Pitton MB. Selective internal radiotherapy (SIRT) versus transarterial chemoembolization (TACE) for the treatment of intrahepatic cholangiocellular carcinoma (CCC): study protocol for a randomized controlled trial. Trials. 2014 Aug 6;15:311. doi: 10.1186/1745-6215-15-311.
Results Reference
derived

Learn more about this trial

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

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