Back to resultsSIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma (SIRTACE)
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Radioembolisation (SIR-Spheres® microspheres)
Transarterial Chemoembolisation
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring HCC, RE, Yttrium-90, SIR-Spheres microspheres, TACE, Radioembolisation, Transarterial Chemoembolisation
Eligibility 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)
Sites / Locations
- Universitäts-Klinikum München-Grosshadern, Medizinische Klinik und Poliklinik II
- Clinica Universitaria de Navarra
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RE
TACE
Arm Description
Device: Radioembolisation with yttrium-90 labelled SIR-Spheres microspheres
Transarterial Chemoembolisation with embolising agent Embospheres and chemotherapeutic agent epirubicin
Outcomes
Primary Outcome Measures
Health-related quality of life (HRQL)
Secondary Outcome Measures
Progression Free Survival (PFS); calculated from the date of first treatment
Morphological tumour response; assessed using RESIST criteria
Functional tumour response; assessed via tumour marker reduction
Survival at 6 and 12 months
Overall survival
Incidence rate of portal vein invasion
Incidence rate of extra-hepatic disease
Pharmaco-economic assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00867750
Brief Title
SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma
Acronym
SIRTACE
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sirtex Medical
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
HCC, RE, Yttrium-90, SIR-Spheres microspheres, TACE, Radioembolisation, Transarterial Chemoembolisation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RE
Arm Type
Experimental
Arm Description
Device: Radioembolisation with yttrium-90 labelled SIR-Spheres microspheres
Arm Title
TACE
Arm Type
Active Comparator
Arm Description
Transarterial Chemoembolisation with embolising agent Embospheres and chemotherapeutic agent epirubicin
Intervention Type
Device
Intervention Name(s)
Radioembolisation (SIR-Spheres® microspheres)
Intervention Description
Yttrium-90 SIR-Spheres microspheres
Intervention Type
Drug
Intervention Name(s)
Transarterial Chemoembolisation
Intervention Description
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 Measure Information:
Title
Health-related quality of life (HRQL)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS); calculated from the date of first treatment
Time Frame
From the date of first treatment until disease progression
Title
Morphological tumour response; assessed using RESIST criteria
Time Frame
From the date of first treatment until disease progression
Title
Functional tumour response; assessed via tumour marker reduction
Time Frame
From the date of first treatment until disease progression
Title
Survival at 6 and 12 months
Time Frame
6 and 12 months from the date of first treatment
Title
Overall survival
Time Frame
From the date of first treatment until death
Title
Incidence rate of portal vein invasion
Time Frame
From the date of first treatment until disease progression
Title
Incidence rate of extra-hepatic disease
Time Frame
From the date of first treatment until disease progression
Title
Pharmaco-economic assessment
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Bruno Sangro, MD, PhD
Organizational Affiliation
Clinica Universitaria de Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Frank Kolligs, PD
Organizational Affiliation
Universitäts-Klinikum München-Grosshadern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäts-Klinikum München-Grosshadern, Medizinische Klinik und Poliklinik II
City
München
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
E-31008
Country
Spain
12. IPD Sharing Statement
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SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma
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