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

Intrahepatic Cholangiocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01798147
• Other study ID #: SIRT-TACE-CCC-Mainz-1
• Status: Recruiting
• Phase: Phase 2
• First received: February 16, 2013
• Last updated: May 21, 2017
• Start date: February 2011
• Est. completion date: June 2018

Study information

• Verified date: May 2017
• Source: Johannes Gutenberg University Mainz
• Contact: Roman Kloeckner, MD
• Phone: ++49613117
• Email: roman.kloeckner[@]unimedizin-mainz.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Cholangiocarcinoma
• Intrahepatic Cholangiocellular Carcinoma

Intervention

Procedure:
• DEB TACE
DEB TACE every 6 weeks until either no viable tumor or endpoint reached.
• SIRT
Selective Internal Radiotherapy once at the beginning of the study. Follow up until endpoint.

Locations

Country	Name	City	State
Germany	Department of Diagnostic and Interventional Radiology	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		at the end of study
Secondary	Overall survival (OS)		at the end of study
Secondary	Time to progression (TTP)		at the end of study