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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798160
• Other study ID #: SIRT-TACE-HCC-Mainz-1
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2013
• Last updated: October 18, 2015
• Start date: February 2010
• Est. completion date: May 2013

Study information

• Verified date: October 2015
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• DEB TACE
DEB TACE every 6 weeks until either no viable tumor or endpoint reached.
• SIRT
Selective Internal Radiation Therapy once at the beginning of the study. Follow up until endpoint.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free-Survival		up to three years
Primary	Overall-Survival		up to three years