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

Hepatocellular Carcinoma Clinical Trial

— SIRTACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867750
• Other study ID #: SX-PHCC-001
• Secondary ID: STX0306
• Status: Completed
• Phase: Phase 2
• First received: March 13, 2009
• Last updated: May 4, 2012
• Start date: March 2006
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: Sirtex Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitäts-Klinikum München-Grosshadern, Medizinische Klinik und Poliklinik II	München
Spain	Clinica Universitaria de Navarra	Pamplona

Sponsors (1)

Lead Sponsor	Collaborator
Sirtex Medical

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life (HRQL)		9 months	No
Secondary	Progression Free Survival (PFS); calculated from the date of first treatment		From the date of first treatment until disease progression	No
Secondary	Morphological tumour response; assessed using RESIST criteria		From the date of first treatment until disease progression	No
Secondary	Functional tumour response; assessed via tumour marker reduction		From the date of first treatment until disease progression	No
Secondary	Survival at 6 and 12 months		6 and 12 months from the date of first treatment	No
Secondary	Overall survival		From the date of first treatment until death	No
Secondary	Incidence rate of portal vein invasion		From the date of first treatment until disease progression	Yes
Secondary	Incidence rate of extra-hepatic disease		From the date of first treatment until disease progression	No
Secondary	Pharmaco-economic assessment		9 months	No