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

NCT01798160 | Completed Phase 4 DMC

• 1 other identifier: SIRT-TACE-HCC-Mainz-1
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression-free-Survival

  up to three years

• Overall-Survival

  up to three years

Study Arms (2)

DEB TACE

ACTIVE COMPARATOR

Drug eluting Beads (DC Beads) loaded with Doxorubicin

Procedure: DEB TACE

SIRT

EXPERIMENTAL

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

Procedure: SIRT

Interventions

DEB TACE PROCEDURE

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

Also known as: Chemoembolization

DEB TACE

SIRT PROCEDURE

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

Also known as: Radioembolization

SIRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Chemoembolization, Therapeutic; Sirtuins

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Embolization, Therapeutic; Hemostatic Techniques; Therapeutics; Therapeutic Occlusion; Group III Histone Deacetylases; Histone Deacetylases; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; ADP Ribose Transferases; Pentosyltransferases; Glycosyltransferases; Transferases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: February 16, 2013
• First Posted: February 25, 2013
• Study Start: February 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 20, 2015

Record last verified: 2015-10