Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).

Phase 4

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT01798160
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2013-02-16
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-25
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-18
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• ≥18 years
• HCC, proven by histology or according to EASL criteria
• Intermediate stage HCC (stage B according to BCLC)
• At least one measurable lesion in magnetic resonance imaging (MRI)
• Tumor load ≤ 50%
• preserved liver function (Child Pugh A and B)

Exclusion Criteria

• Patients feasible for curative treatment (e.g. resection or local ablation)
• Previous TACE or SIRT
• Chemotherapy during the last 4 weeks
• Child Pugh stage C
• BCLC stage D
• ECOG Performance Status >0
• 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 portal vein
• Hepatofugal blood flow in the portal vein
• Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan
• Contraindications against angiography
• Gravidity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression-free-Survival	up to three years
Overall-Survival	up to three years