Uveal MelanomaPhase 2SirTacNCT02936388
Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis
A Phase 2 study testing SIRT and DSM-TACE in people with Uveal Melanoma, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Characterisation of effect of SIRT and DSM-TACE as local treatment options for liver metastases in patients with advanced uveal melanoma with respect to progression-free survival and exploratory comparison of secondary endpoints regarding application, activity, adverse effects and impact on quality of life in a… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- SIRT and DSM-TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2016to Dec 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG Performance Status of 0, 1 or 2
- Histologically or cytologically confirmed liver metastases of uveal melanoma
- At least one measurable lesion according to RECIST criteria v1.1 determined MRI (if contraindications against MRI exist CT with contrast media can is allowed)
- Metastases in other sides are allowed if not in need of treatment (e.g. asymptomatic bone metastasis without indication for radiation)
- Prior treatment with systemic anti-cancer therapy is allowed if terminated ≥ 4 weeks prior to study treatment start and recovery from toxicity is achieved
- Surgery in general and hepatic surgery in particular (e.g. lobe resection, radiofrequency ablation) prior to study enrollment are allowed if realized ≥ 4 weeks prior to study enrollment and recovery from surgery is achieved
Who cannot join
- Surgically treatable liver metastases
- Previous intraarterial hepatic treatment (e.g. radioembolisation, chemoembolisation, intraarterial chemotherapy, isolated or percutaneous hepatic perfusion)
- Previous treatment with external liver radiation
- Major intrahepatic occlusion of the portal vein and/or tumor infiltration of the portal vein
- Liver cirrhosis Child-Pugh C
- Progressive liver failure
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- Renale failure, bone marrow insufficiency, coagulopathy
- Uncontrolled or severe medical conditions which could impair the ability to participate in the trial such as unstable cardiac disease or uncontrolled infection
- Other malignancy and/or metastases in need of treatment
- Current treatment with any anti-cancer therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - University Medicine Berlin, Dept. of Haematology, Medical Oncology and Tumor Immunology, Campus Benjamin Franklin
Berlin, 12200
About this study
Official title: A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma
Characterisation of effect of SIRT and DSM-TACE as local treatment options for liver metastases in patients with advanced uveal melanoma with respect to progression-free survival and exploratory comparison of secondary endpoints regarding application, activity, adverse effects and impact on quality of life in a randomized study design.
Read the detailed description
This is a randomized phase II trial to evaluate the effect of transarterial radioembolisation with yttrium-90 microspheres (SIRT) and transarterial chemoembolisation with cisplatin (DSM-TACE) in patients with liver metastases due to advanced uveal melanoma in terms of progression-free survival and multiple secondary endpoints.
Patients in study arm A will receive transarterial radioembolisation one time only. Patients in study arm B will receive transarterial chemoembolisation every 4 to 6 weeks until complete tumor devascularisation is observed or disease progression or intolerable toxicity occur. At the time of local tumor progression patients will be offered the other treatment respectively (either SIRT or DSM-TACE) as part of the study.
- Conditions
- Uveal Melanoma
- Being tested
- SIRT, DSM-TACE
- Keywords
- uveal melanoma, liver metastasis, chemoembolisation, radioembolisation
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIRTProcedure or surgery
Also called Drug: Yttrium-90 microspheres (SIR-Spheres®)
catheter-based application of radioactive microspheres into the hepatic artery
DSM-TACEProcedure or surgery
Also called Drug: Cisplatin and EmboCept®
catheter-based application of chemotherapy and degradable starch microspheres into the hepatic artery
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | SIRT: Transarterial radioembolisation with Yttrium-90-bearing resin microspheres (SIR-Spheres®) Receives: Procedure: SIRT |
| Arm B | Active comparator | DSM-TACE: Transarterial chemoembolisation with Cisplatin and EmboCept® S starch microspheres (PharmaCept GmbH) Receives: Procedure: DSM-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregression-free survival (PFS)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2024
- Study completionDec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Anna Peuker, Charite University, Berlin, Germany
- Investigators
- Ulrich Keilholz, Prof. Dr. med., Principal investigator, Charité Universitätsmedizin Berlin, Charité Comprehensive Cancer Center (CCCC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936388
- Sponsor's protocol ID
- SirTac2014
- Acronym
- SirTac
- Status last verified
- Jan 2025
- First submitted
- 9 Sep 2016
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma
- ClinicalTrials.gov ID
- NCT02936388
- Acronym / sponsor ID
- SirTac / SirTac2014
- Conditions
- Uveal Melanoma
- Keywords
- uveal melanoma, liver metastasis, chemoembolisation, radioembolisation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2024 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 18 Oct 2016 (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.
Characterisation of effect of SIRT and DSM-TACE as local treatment options for liver metastases in patients with advanced uveal melanoma with respect to progression-free survival and exploratory comparison of secondary endpoints regarding application, activity, adverse effects and impact on quality of life in a randomized study design.
Detailed description
This is a randomized phase II trial to evaluate the effect of transarterial radioembolisation with yttrium-90 microspheres (SIRT) and transarterial chemoembolisation with cisplatin (DSM-TACE) in patients with liver metastases due to advanced uveal melanoma in terms of progression-free survival and multiple secondary endpoints.
Patients in study arm A will receive transarterial radioembolisation one time only. Patients in study arm B will receive transarterial chemoembolisation every 4 to 6 weeks until complete tumor devascularisation is observed or disease progression or intolerable toxicity occur. At the time of local tumor progression patients will be offered the other treatment respectively (either SIRT or DSM-TACE) as part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Procedure: SIRTSIRT: Transarterial radioembolisation with Yttrium-90-bearing resin microspheres (SIR-Spheres®) |
| Arm B | Active comparator | Procedure: DSM-TACEDSM-TACE: Transarterial chemoembolisation with Cisplatin and EmboCept® S starch microspheres (PharmaCept GmbH) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECOG Performance Status of 0, 1 or 2
- Histologically or cytologically confirmed liver metastases of uveal melanoma
- At least one measurable lesion according to RECIST criteria v1.1 determined MRI (if contraindications against MRI exist CT with contrast media can is allowed)
- Metastases in other sides are allowed if not in need of treatment (e.g. asymptomatic bone metastasis without indication for radiation)
- Prior treatment with systemic anti-cancer therapy is allowed if terminated ≥ 4 weeks prior to study treatment start and recovery from toxicity is achieved
Key exclusion criteria (10 listed)
- Surgically treatable liver metastases
- Previous intraarterial hepatic treatment (e.g. radioembolisation, chemoembolisation, intraarterial chemotherapy, isolated or percutaneous hepatic perfusion)
- Previous treatment with external liver radiation
- Major intrahepatic occlusion of the portal vein and/or tumor infiltration of the portal vein
- Liver cirrhosis Child-Pugh C
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 |
|---|---|---|
| SIRTAlso: Drug: Yttrium-90 microspheres (SIR-Spheres®)catheter-based application of radioactive microspheres into the hepatic artery | Procedure or surgery | Arm A |
| DSM-TACEAlso: Drug: Cisplatin and EmboCept®catheter-based application of chemotherapy and degradable starch microspheres into the hepatic artery | Procedure or surgery | Arm B |
Primary outcome
Pregression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 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 24 Jan 2025.
- Individual participant dataSharing planned: Yes
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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.
Ulrich Keilholz, Prof. Dr. med. principal investigator
Charité Universitätsmedizin Berlin, Charité Comprehensive Cancer Center (CCCC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SIRT and DSM-TACE in people with Uveal Melanoma, run by Charite University, Berlin, Germany at 1 site in Germany.
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 10 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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Pregression-free survival (PFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 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 24 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.