Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).

NCT ID: NCT01798160

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-05-31

Brief Summary

Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Study Design

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

Study Groups

DEB TACE

Drug eluting Beads (DC Beads) loaded with Doxorubicin

Group Type: ACTIVE_COMPARATOR

DEB TACE

Intervention Type: PROCEDURE

DEB TACE every 6 weeks until either no viable tumor or endpoint reached.

SIRT

Selective Internal Radiation Therapy using Yttrium 90 loaded resin beads (Sir Spheres)

Group Type: EXPERIMENTAL

SIRT

Intervention Type: PROCEDURE

Selective Internal Radiation Therapy once at the beginning of the study. Follow up until endpoint.

Interventions

DEB TACE

DEB TACE every 6 weeks until either no viable tumor or endpoint reached.

Intervention Type: PROCEDURE

SIRT

Selective Internal Radiation Therapy once at the beginning of the study. Follow up until endpoint.

Intervention Type: PROCEDURE

Other Intervention Names

Chemoembolization; Radioembolization

Eligibility Criteria

Inclusion Criteria

• ≥18 years
• HCC, proven by histology or according to EASL criteria
• Intermediate stage HCC (stage B according to BCLC)
• At least one measurable lesion in magnetic resonance imaging (MRI)
• Tumor load ≤ 50%
• preserved liver function (Child Pugh A and B)

Exclusion Criteria

• Patients feasible for curative treatment (e.g. resection or local ablation)
• Previous TACE or SIRT
• Chemotherapy during the last 4 weeks
• Child Pugh stage C
• BCLC stage D
• ECOG Performance Status >0
• Tumor involvement >50% of the liver
• Extrahepatic tumor
• Serum Bilirubin >2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine >2 mg/dl; Leukocytes <3000/ml; Thrombocytes <50000/ml
• Esophageal bleeding during the last 3 months
• Hepatic encephalopathy
• Transjugular intrahepatic portosystemic shunt (TIPS)
• Infiltration or occlusion of the portal vein
• Hepatofugal blood flow in the portal vein
• Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan
• Contraindications against angiography
• Gravidity

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

Sponsors

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Michael Bernhard Pitton

Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SIRT-TACE-HCC-Mainz-1

Identifier Type: -

Identifier Source: org_study_id