Radioembolization versus Chemoembolization for the treatment of primary liver cancer: A multicenter study

• Conditions: Patients with intermediate stage hepatocellualr carcinoma.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001794-85-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-26
• Last Update Posted: 9 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

- Diagnosis HCC
- Intermediate stage HCC as defined by the BCLC criteria, i.e. >3 lesions >3cm in size, or 1 lesion >5cm in size (BCLC stage B )
- absence of extrahepatic disease
- Age > 18 years
- Child-Pugh A-B7
- ECOG performance status (PST) 0-1
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

- Inadequate bone marrow function (hemoglobulin <6.0 mmol/l, absolute neutrophil count < 1.5 x 109/l, platelet count <60 x 109/l)
- Inadequate liver function (bilirubin >45 µmol/l (or 2.6 mg/dl), albumin <28 g/l, AST/ALT >5x upper limit of normal (ULN))
- Inadequate renal function (creatinine >1.5x ULN)
- Compromised biliary system
- Hypersensivity to doxorubicin
- Pregnancy or breast feeding
- >50% of liver involvement
- main portal vein (right, left or common trunk) thrombosis
- Patients who are declared incompetent or suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis
- Previous local treatment of study target lesion(s)
- Allergy for i.v. contrast used (Visipaque®)
- Life expectancy <3 months or otherwise impossible follow-up
- Patients in whom hepatic artery catheterization is contraindicated; such as patients with vascular abnormalities or bleeding diathesis (indicated by a PT >6 seconds over control)

Study & Design

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