Trial record 1 of 1 for:    NCT00867750
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SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma (SIRTACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sirtex Medical
ClinicalTrials.gov Identifier:
NCT00867750
First received: March 13, 2009
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
Device: Radioembolisation (SIR-Spheres® microspheres)
Drug: Transarterial Chemoembolisation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Sirtex Medical:

Primary Outcome Measures:
  • Health-related quality of life (HRQL) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS); calculated from the date of first treatment [ Time Frame: From the date of first treatment until disease progression ] [ Designated as safety issue: No ]
  • Morphological tumour response; assessed using RESIST criteria [ Time Frame: From the date of first treatment until disease progression ] [ Designated as safety issue: No ]
  • Functional tumour response; assessed via tumour marker reduction [ Time Frame: From the date of first treatment until disease progression ] [ Designated as safety issue: No ]
  • Survival at 6 and 12 months [ Time Frame: 6 and 12 months from the date of first treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From the date of first treatment until death ] [ Designated as safety issue: No ]
  • Incidence rate of portal vein invasion [ Time Frame: From the date of first treatment until disease progression ] [ Designated as safety issue: Yes ]
  • Incidence rate of extra-hepatic disease [ Time Frame: From the date of first treatment until disease progression ] [ Designated as safety issue: No ]
  • Pharmaco-economic assessment [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: March 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867750

Locations
Germany
Universitäts-Klinikum München-Grosshadern, Medizinische Klinik und Poliklinik II
München, Germany, D-81377
Spain
Clinica Universitaria de Navarra
Pamplona, Spain, E-31008
Sponsors and Collaborators
Sirtex Medical
Investigators
Principal Investigator: Dr Bruno Sangro, MD, PhD Clinica Universitaria de Navarra
Principal Investigator: Dr. Frank Kolligs, PD Universitäts-Klinikum München-Grosshadern
  More Information

No publications provided

Responsible Party: Sirtex Medical
ClinicalTrials.gov Identifier: NCT00867750     History of Changes
Other Study ID Numbers: SX-PHCC-001, STX0306
Study First Received: March 13, 2009
Last Updated: May 4, 2012
Health Authority: European Union: European Medicines Agency

Keywords provided by Sirtex Medical:
HCC
RE
Yttrium-90
SIR-Spheres microspheres
TACE
Radioembolisation
Transarterial Chemoembolisation

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014