Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).
1 other identifier
interventional
24
1 country
1
Brief Summary
Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 16, 2013
CompletedFirst Posted
Study publicly available on registry
February 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMay 23, 2017
May 1, 2017
7.3 years
February 16, 2013
May 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
at the end of study
Secondary Outcomes (2)
Overall survival (OS)
at the end of study
Time to progression (TTP)
at the end of study
Study Arms (2)
DEB TACE
ACTIVE COMPARATORDrug eluting Beads (DC Beads) loaded with Doxorubicin
SIRT
EXPERIMENTALSelective Internal Radiotherapy using Yttrium 90 loaded resin beads (Sir Spheres)
Interventions
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Diagnostic and Interventional Radiology
Mainz, 55131, Germany
Related Publications (1)
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.
PMID: 25095718DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
February 16, 2013
First Posted
February 25, 2013
Study Start
February 1, 2011
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
May 23, 2017
Record last verified: 2017-05