Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

DEB TACE

SIRT

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

DEB TACE

SIRT

Arm Description

Drug eluting Beads (DC Beads) loaded with Doxorubicin

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

Outcomes

Primary Outcome Measures

Progression-free-Survival

Overall-Survival

Secondary Outcome Measures

Full Information

NCT ID

NCT01798160

First Posted

February 16, 2013

Last Updated

October 18, 2015

Sponsor

Johannes Gutenberg University Mainz

1. Study Identification

Unique Protocol Identification Number

NCT01798160

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johannes Gutenberg University Mainz

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DEB TACE

Arm Type

Active Comparator

Arm Description

Drug eluting Beads (DC Beads) loaded with Doxorubicin

Arm Title

SIRT

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

DEB TACE

Other Intervention Name(s)

Chemoembolization

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

SIRT

Other Intervention Name(s)

Radioembolization

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free-Survival

Time Frame

up to three years

Title

Overall-Survival

Time Frame

up to three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs