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

NCT ID: NCT00867750

Last Updated: 2012-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2011-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RE

Device: Radioembolisation with yttrium-90 labelled SIR-Spheres microspheres

Group Type: EXPERIMENTAL

Radioembolisation (SIR-Spheres® microspheres)

Intervention Type: DEVICE

Yttrium-90 SIR-Spheres microspheres

TACE

Transarterial Chemoembolisation with embolising agent Embospheres and chemotherapeutic agent epirubicin

Group Type: ACTIVE_COMPARATOR

Transarterial Chemoembolisation

Intervention Type: DRUG

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.

Interventions

Radioembolisation (SIR-Spheres® microspheres)

Yttrium-90 SIR-Spheres microspheres

Intervention Type: DEVICE

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female patients, aged ≥ 18 years
• Unequivocal diagnosis of primary HCC (confirmed by biopsy/histology or EASL criteria)
• Tumour characteristics as follows:

• Not more than 5 lesions
• If single, maximal diameter ≤ 10 cm
• If multiple, sum of maximal diameters ≤ 15 cm
• Lesions satellite to primary tumour of less than 1 cm in maximal diameter are not included
• At least one quantifiable lesion on hepatic MRI
• Preserved liver function, corresponding to Child-Pugh class ≤ B-7
• ECOG performance status ≤ 2
• Life expectancy ≥ 12 weeks
• Female patients of childbearing potential must have a negative pregnancy test prior to inclusion in the trial and male and female patients must agree to use an effective contraceptive method for the duration of the trial.
• Willing and able to provide written informed consent

Exclusion Criteria

• Patients expected to undergo surgery (resection or transplantation) within the 24-week period after randomisation.
• Ascites, which is detectable on physical examination or clinically symptomatic (but patients having ascites discovered by imaging only should not be excluded).
• Serum transaminases > 5 x ULN
• Lung shunt > 20%
• Extrahepatic disease
• Moderate to severe portal hypertension, as evidenced by any of the following criteria (occurring in spite of using common criteria for prophylactic treatment and therapy):

• History of variceal haemorrhage in past 2 years
• History of hepatic encephalopathy
• Platelets < 50.000 /ml
• WBC < 3.000 / ml
• Previous TIPSS procedure
• Portal vein occlusion or hepatofugal flow.
• Impaired liver function

• Total serum bilirubin > 2.0 mg / dL
• Serum albumin < 3.0 g /dl
• creatinine > 2 mg / dL
• Chemotherapy or other experimental therapy within preceding 4 weeks
• Previous TAE / TACE
• Previous radiation therapy to liver or lungs
• Contraindications for angiography (severe peripheral vascular disease or uncorrectable bleeding diathesis)
• Anatomical variants apparent on 99mTc-MAA scan precluding safe administration of RE
• Any decompensated concomitant disease
• Female patients who are pregnant, breast-feeding, or pre-menopausal and not practising efficient contraceptive method (hormonal contraceptive, intra-uterine device)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sirtex Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Bruno Sangro, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinica Universitaria de Navarra

Dr. Frank Kolligs, PD

Role: PRINCIPAL_INVESTIGATOR

Universitäts-Klinikum München-Grosshadern

Locations

Universitäts-Klinikum München-Grosshadern, Medizinische Klinik und Poliklinik II

München, , Germany

Clinica Universitaria de Navarra

Pamplona, , Spain

Countries

Germany; Spain

Other Identifiers

STX0306

Identifier Type: -

Identifier Source: secondary_id

SX-PHCC-001

Identifier Type: -

Identifier Source: org_study_id