Status:
UNKNOWN
Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).
Lead Sponsor:
Johannes Gutenberg University Mainz
Conditions:
Intrahepatic Cholangiocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01798147
Start Date
February 1 2011
End Date
June 1 2018
Last Update
May 23 2017
Active Locations (1)
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1
Department of Diagnostic and Interventional Radiology
Mainz, Germany, 55131