Study of Radioembolization (RE) with SIR-Spheres® versus Transarterial Chemoembolisation (TACE) in patients with unresectable primary Hepatocellular Carcinoma. A comparative, prospective, randomised, open, pilot trial to evaluate health-related quality of life, pharmaco-economic parameters, and efficacy. - SIRTACE-HCC pilot study

• Conditions: nresectable primary hepatocellular carcinoma (pHCC); MedDRA version: 9.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectable

• Registration Number: EUCTR2006-006478-79-DE
• Lead Sponsor: SIRTEX Medical Europe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-16
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Patients with unresectable pHCC,
diagnosis established according to EASL criteria, and
- Liver function: Child-Pugh A
- Performance status: ECOG < 2
- Tumour lesions: < 5 in number and < 20 cm in cumulative sum of maximum
diameters
- Life expectancy > 12 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(1) Patients expected to undergo surgery (resection or transplantation) within the
24-week period after randomization.
(2) Ascites, detectable on physical examination or clinically symptomatic
(3) Serum transaminases higher than 5 times the upper normal limit
(4) Serum bilirubin > 2 mg/dL
(5) Lung shunt > 15%
(6) Extrahepatic disease
(7) Moderate to severe portal hypertension
(10) Impaired renal function (creatinine > 2 mg / dl)
(11) Chemotherapy or other experimental therapy within preceding 4 weeks
(12) Previous TAE / TACE
(13) Previous radiation therapy to liver or lungs
(14) Contraindications for angiography (severe peripheral vascular disease or
uncorrectable bleeding diathesis)
(15) Anatomical variants apparent on 99mTc-MAA scan precluding safe
administration of RE
(16) Any decompensated concomitant disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of health-related quality of life after radioembolization (RE) with SIR-Spheres versus Transarterial Chemoembolisation (TACE) in patients with unresectable, primary hepatocellular carcinoma.;Secondary Objective: Comparative evaluation of pharmaco-economic parameters and explorative comparison of safety and efficacy of RE and TACE;Primary end point(s): The primary objective of this trial is to assess health-related quality of life (HRQL) following RE or TACE at 3, 6, and 9 months following the first treatment with either modality (HRQL3M, HRQL6M, HRQL9M), using the FACT-Hep questionnaire. The primary endpoint, therefore, is the total FACT-Hep score per treatment group at 3, 6, and 9 months.