NCT00867750

SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma

Radioembolisation (RE) With SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation (TACE) in Patients With Unresectable Hepatocellular Carcinoma (HCC). A Comparative, Prospective, Randomised, Open, Pilot Study.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Sirtex Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to patients with primary HCC who cannot be treated by potentially curative treatment modalities, such as surgical resection, liver transplantation or percutaneous ablation. Patients that satisfy the study eligibility criteria will be randomised in a 1: 1 ratio to receive either Radioembolisation with SIR-Spheres Microspheres or the standardised Transarterial Chemoembolisation procedure. Study Objectives This study will evaluate and compare quality of life as well as safety and efficacy of RE or TACE in patients with unresectable HCC. Patients will be followed for a minimum of 12 months or until death wherever possible in the evaluation of the primary and secondary objectives of this study.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DEVICE	Radioembolisation (SIR-Spheres® microspheres)	Yttrium-90 SIR-Spheres microspheres
DRUG	Transarterial Chemoembolisation	TACE with embolising agent Embospheres (150-300 μm or 300-500 μm diameter) with 50 mg of chemotherapeutic agent epirubicin admixed with 5 ml lipiodol.

Timeline

• Start date: 2006-03-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-03-24
• Last updated: 2012-05-07

Locations

2 sites across 2 countries: Germany, Spain