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

• ClinicalTrials.gov Identifier: NCT00867750
• Recruitment Status: Completed
• First Posted: March 24, 2009
• Last Update Posted: May 7, 2012
• Sponsor: Sirtex Medical
• Information provided by (Responsible Party): Sirtex Medical

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Sirtex Medical
• ClinicalTrials.gov Identifier: NCT00867750
• Other Study ID Numbers: SX-PHCC-001; STX0306
• First Posted: March 24, 2009
• Last Update Posted: May 7, 2012
• Last Verified: May 2012

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