SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma (SIRTACE)

May 4, 2012 updated by: Sirtex Medical

Radioembolisation (RE) With SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation (TACE) in Patients With Unresectable Hepatocellular Carcinoma (HCC). A Comparative, Prospective, Randomised, Open, Pilot Study.

This study is open to patients with primary HCC who cannot be treated by potentially curative treatment modalities, such as surgical resection, liver transplantation or percutaneous ablation.

Patients that satisfy the study eligibility criteria will be randomised in a 1: 1 ratio to receive either Radioembolisation with SIR-Spheres Microspheres or the standardised Transarterial Chemoembolisation procedure.

Study Objectives

This study will evaluate and compare quality of life as well as safety and efficacy of RE or TACE in patients with unresectable HCC. Patients will be followed for a minimum of 12 months or until death wherever possible in the evaluation of the primary and secondary objectives of this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • München, Germany, D-81377
        • Universitäts-Klinikum München-Grosshadern, Medizinische Klinik und Poliklinik II
  • Spain
      • Pamplona, Spain, E-31008
        • Clínica Universitaria de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients, aged ≥ 18 years
  • Unequivocal diagnosis of primary HCC (confirmed by biopsy/histology or EASL criteria)

  • Tumour characteristics as follows:

    • Not more than 5 lesions
    • If single, maximal diameter ≤ 10 cm
    • If multiple, sum of maximal diameters ≤ 15 cm
    • Lesions satellite to primary tumour of less than 1 cm in maximal diameter are not included
    • At least one quantifiable lesion on hepatic MRI
  • Preserved liver function, corresponding to Child-Pugh class ≤ B-7
  • ECOG performance status ≤ 2
  • Life expectancy ≥ 12 weeks
  • Female patients of childbearing potential must have a negative pregnancy test prior to inclusion in the trial and male and female patients must agree to use an effective contraceptive method for the duration of the trial.
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Patients expected to undergo surgery (resection or transplantation) within the 24-week period after randomisation.
  • Ascites, which is detectable on physical examination or clinically symptomatic (but patients having ascites discovered by imaging only should not be excluded).
  • Serum transaminases > 5 x ULN
  • Lung shunt > 20%
  • Extrahepatic disease

  • Moderate to severe portal hypertension, as evidenced by any of the following criteria (occurring in spite of using common criteria for prophylactic treatment and therapy):

    • History of variceal haemorrhage in past 2 years
    • History of hepatic encephalopathy
    • Platelets < 50.000 /ml
    • WBC < 3.000 / ml
    • Previous TIPSS procedure
  • Portal vein occlusion or hepatofugal flow.

  • Impaired liver function

    • Total serum bilirubin > 2.0 mg / dL
    • Serum albumin < 3.0 g /dl
    • creatinine > 2 mg / dL
  • Chemotherapy or other experimental therapy within preceding 4 weeks
  • Previous TAE / TACE
  • Previous radiation therapy to liver or lungs
  • Contraindications for angiography (severe peripheral vascular disease or uncorrectable bleeding diathesis)
  • Anatomical variants apparent on 99mTc-MAA scan precluding safe administration of RE
  • Any decompensated concomitant disease
  • Female patients who are pregnant, breast-feeding, or pre-menopausal and not practising efficient contraceptive method (hormonal contraceptive, intra-uterine device)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RE
Device: Radioembolisation with yttrium-90 labelled SIR-Spheres microspheres
Device: Radioembolisation (SIR-Spheres® microspheres)
Yttrium-90 SIR-Spheres microspheres
Active Comparator: TACE
Transarterial Chemoembolisation with embolising agent Embospheres and chemotherapeutic agent epirubicin
Drug: Transarterial Chemoembolisation
TACE with embolising agent Embospheres (150-300 μm or 300-500 μm diameter) with 50 mg of chemotherapeutic agent epirubicin admixed with 5 ml lipiodol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health-related quality of life (HRQL)
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS); calculated from the date of first treatment
Time Frame: From the date of first treatment until disease progression
From the date of first treatment until disease progression
Morphological tumour response; assessed using RESIST criteria
Time Frame: From the date of first treatment until disease progression
From the date of first treatment until disease progression
Functional tumour response; assessed via tumour marker reduction
Time Frame: From the date of first treatment until disease progression
From the date of first treatment until disease progression
Survival at 6 and 12 months
Time Frame: 6 and 12 months from the date of first treatment
6 and 12 months from the date of first treatment
Overall survival
Time Frame: From the date of first treatment until death
From the date of first treatment until death
Incidence rate of portal vein invasion
Time Frame: From the date of first treatment until disease progression
From the date of first treatment until disease progression
Incidence rate of extra-hepatic disease
Time Frame: From the date of first treatment until disease progression
From the date of first treatment until disease progression
Pharmaco-economic assessment
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sirtex Medical

Investigators

  • Principal Investigator: Dr Bruno Sangro, MD, PhD, Clínica Universitaria de Navarra
  • Principal Investigator: Dr. Frank Kolligs, PD, Universitäts-Klinikum München-Grosshadern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 13, 2009

First Submitted That Met QC Criteria

March 20, 2009

First Posted (Estimate)

March 24, 2009

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SX-PHCC-001
  • STX0306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma

Clinical Trials on Radioembolisation (SIR-Spheres® microspheres)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe