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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00867750
Recruitment Status : Completed
First Posted : March 24, 2009
Last Update Posted : May 7, 2012
Information provided by (Responsible Party):
Sirtex Medical

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Device: Radioembolisation (SIR-Spheres® microspheres) Drug: Transarterial Chemoembolisation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radioembolisation (RE) With SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation (TACE) in Patients With Unresectable Hepatocellular Carcinoma (HCC). A Comparative, Prospective, Randomised, Open, Pilot Study.
Study Start Date : March 2006
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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.

Primary Outcome Measures :
  1. Health-related quality of life (HRQL) [ Time Frame: 9 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00867750

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Universitäts-Klinikum München-Grosshadern, Medizinische Klinik und Poliklinik II
München, Germany, D-81377
Clinica Universitaria de Navarra
Pamplona, Spain, E-31008
Sponsors and Collaborators
Sirtex Medical
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Principal Investigator: Dr Bruno Sangro, MD, PhD Clinica Universitaria de Navarra
Principal Investigator: Dr. Frank Kolligs, PD Universitäts-Klinikum München-Grosshadern
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Responsible Party: Sirtex Medical Identifier: NCT00867750    
Other Study ID Numbers: SX-PHCC-001
First Posted: March 24, 2009    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012
Keywords provided by Sirtex Medical:
SIR-Spheres microspheres
Transarterial Chemoembolisation
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases