Hepatocellular CarcinomaPhase 4NCT01798160
Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).
A Phase 4 study testing DEB TACE and SIRT in people with Hepatocellular Carcinoma, run by Johannes Gutenberg University Mainz.
Trial summary
Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma. 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?
- DEB TACE and SIRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to May 2013
- Phase
- Phase 4
- 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
- ≥18 years
- HCC, proven by histology or according to EASL criteria
- Intermediate stage HCC (stage B according to BCLC)
- At least one measurable lesion in magnetic resonance imaging (MRI)
- Tumor load ≤ 50%
- preserved liver function (Child Pugh A and B)
Who cannot join
- Patients feasible for curative treatment (e.g. resection or local ablation)
- Previous TACE or SIRT
- Chemotherapy during the last 4 weeks
- Child Pugh stage C
- BCLC stage D
- ECOG Performance Status >0
Show all 18Show fewer
- Tumor involvement >50% of the liver
- Extrahepatic tumor
- Serum Bilirubin >2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine >2 mg/dl; Leukocytes <3000/ml; Thrombocytes <50000/ml
- Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
- Esophageal bleeding during the last 3 months
- Hepatic encephalopathy
- Transjugular intrahepatic portosystemic shunt (TIPS)
- Infiltration or occlusion of the portal vein
- Hepatofugal blood flow in the portal vein
- Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan
- Contraindications against angiography
- Gravidity
About this study
Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- DEB TACE, SIRT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB TACEProcedure or surgery
Also called Chemoembolization
DEB TACE every 6 weeks until either no viable tumor or endpoint reached.
SIRTProcedure or surgery
Also called Radioembolization
Selective Internal Radiation Therapy once at the beginning of the study. Follow up until endpoint.
| Study group | Role | What they receive |
|---|---|---|
| DEB TACE | Active comparator | Drug eluting Beads (DC Beads) loaded with Doxorubicin Receives: Procedure: DEB TACE |
| SIRT | Experimental | Selective Internal Radiation Therapy using Yttrium 90 loaded resin beads (Sir Spheres) Receives: Procedure: SIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free-Survival
Measured: up to three years
Overall-Survival
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startFeb 2010
- Primary completionMay 2013
- Study completionMay 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Bernhard Pitton, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798160
- Sponsor's protocol ID
- SIRT-TACE-HCC-Mainz-1
- Status last verified
- Oct 2015
- First submitted
- 16 Feb 2013
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Internal Radiation Therapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Hepatocellular Carcinoma (HCC).
- ClinicalTrials.gov ID
- NCT01798160
- Acronym / sponsor ID
- SIRT-TACE-HCC-Mainz-1
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Feb 2013 (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.
Selective Internal Radiation Therapy is superior to Transarterial Chemoembolisation for the treatment of intermediate stage hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEB TACE | Active comparator | Procedure: DEB TACEDrug eluting Beads (DC Beads) loaded with Doxorubicin |
| SIRT | Experimental | Procedure: SIRTSelective Internal Radiation Therapy using Yttrium 90 loaded resin beads (Sir Spheres) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years
- HCC, proven by histology or according to EASL criteria
- Intermediate stage HCC (stage B according to BCLC)
- At least one measurable lesion in magnetic resonance imaging (MRI)
- Tumor load ≤ 50%
Key exclusion criteria (18 listed)
- Patients feasible for curative treatment (e.g. resection or local ablation)
- Previous TACE or SIRT
- Chemotherapy during the last 4 weeks
- Child Pugh stage C
- BCLC stage D
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 |
|---|---|---|
| DEB TACEAlso: ChemoembolizationDEB TACE every 6 weeks until either no viable tumor or endpoint reached. | Procedure or surgery | DEB TACE |
| SIRTAlso: RadioembolizationSelective Internal Radiation Therapy once at the beginning of the study. Follow up until endpoint. | Procedure or surgery | SIRT |
Primary outcome
Progression-free-Survival
Time frame: up to three years
Overall-Survival
Time frame: up to three years
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 20 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DEB TACE and SIRT in people with Hepatocellular Carcinoma, run by Johannes Gutenberg University Mainz.
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 6 inclusion and 18 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 20 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Progression-free-Survival (time frame: up to three years). The study lists 2 primary outcomes in all. 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 20 Oct 2015.