Hepatocellular CarcinomaPhase 2SIRTACENCT00867750
SIR-Spheres® Microspheres Versus Transarterial Chemoembolisation in Patients With Unresectable Hepatocellular Carcinoma
A Phase 2 study testing Radioembolisation (SIR-Spheres® microspheres) and Transarterial Chemoembolisation in people with Hepatocellular Carcinoma, run by Sirtex Medical at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Radioembolisation (SIR-Spheres® microspheres) and Transarterial Chemoembolisation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2006to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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):
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- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Universitäts-Klinikum München-Grosshadern, Medizinische Klinik und Poliklinik II
München, D-81377
About this study
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.
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.
Read more
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Radioembolisation (SIR-Spheres® microspheres), Transarterial Chemoembolisation
- Keywords
- HCC, RE, Yttrium-90, SIR-Spheres microspheres, TACE, Radioembolisation, Transarterial Chemoembolisation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioembolisation (SIR-Spheres® microspheres)Device
Yttrium-90 SIR-Spheres microspheres
Transarterial ChemoembolisationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| RE | Experimental | Device: Radioembolisation with yttrium-90 labelled SIR-Spheres microspheres Receives: Device: Radioembolisation (SIR-Spheres® microspheres) |
| TACE | Active comparator | Transarterial Chemoembolisation with embolising agent Embospheres and chemotherapeutic agent epirubicin Receives: Drug: Transarterial Chemoembolisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (HRQL)
Measured: 9 months
Secondary outcomes (8)
Progression Free Survival (PFS); calculated from the date of first treatment
Measured: From the date of first treatment until disease progression
Morphological tumour response; assessed using RESIST criteria
Measured: From the date of first treatment until disease progression
Functional tumour response; assessed via tumour marker reduction
Measured: From the date of first treatment until disease progression
Survival at 6 and 12 months
Measured: 6 and 12 months from the date of first treatment
Overall survival
Measured: From the date of first treatment until death
Incidence rate of portal vein invasion
Measured: From the date of first treatment until disease progression
Incidence rate of extra-hepatic disease
Measured: From the date of first treatment until disease progression
Pharmaco-economic assessment
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startMar 2006
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirtex Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Bruno Sangro, MD, PhD, Principal investigator, Clinica Universitaria de NavarraDr. Frank Kolligs, PD, Principal investigator, Universitäts-Klinikum München-Grosshadern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867750
- Sponsor's protocol ID
- SX-PHCC-001
- Other IDs
- STX0306
- Acronym
- SIRTACE
- Status last verified
- May 2012
- First submitted
- 13 Mar 2009
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00867750
- Acronym / sponsor ID
- SIRTACE / SX-PHCC-001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, RE, Yttrium-90, SIR-Spheres microspheres, TACE, Radioembolisation, Transarterial Chemoembolisation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sirtex MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RE | Experimental | Device: Radioembolisation (SIR-Spheres® microspheres)Device: Radioembolisation with yttrium-90 labelled SIR-Spheres microspheres |
| TACE | Active comparator | Drug: Transarterial ChemoembolisationTransarterial Chemoembolisation with embolising agent Embospheres and chemotherapeutic agent epirubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female patients, aged ≥ 18 years
- Unequivocal diagnosis of primary HCC (confirmed by biopsy/histology or EASL criteria)
- Tumour characteristics as follows:
- Preserved liver function, corresponding to Child-Pugh class ≤ B-7
- ECOG performance status ≤ 2
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radioembolisation (SIR-Spheres® microspheres)Yttrium-90 SIR-Spheres microspheres | Device | RE |
| Transarterial ChemoembolisationTACE with embolising agent Embospheres (150-300 μm or 300-500 μm diameter) with 50 mg of chemotherapeutic agent epirubicin admixed with 5 ml lipiodol. | Drug | TACE |
Primary outcome
Health-related quality of life (HRQL)
Time frame: 9 months
8 secondary outcomes
Progression Free Survival (PFS); calculated from the date of first treatment
Time frame: 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
Functional tumour response; assessed via tumour marker reduction
Time frame: 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
Overall survival
Time frame: 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
Incidence rate of extra-hepatic disease
Time frame: From the date of first treatment until disease progression
Pharmaco-economic assessment
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Bruno Sangro, MD, PhD principal investigator
Clinica Universitaria de Navarra
Dr. Frank Kolligs, PD principal investigator
Universitäts-Klinikum München-Grosshadern
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radioembolisation (SIR-Spheres® microspheres) and Transarterial Chemoembolisation in people with Hepatocellular Carcinoma, run by Sirtex Medical at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQL) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.