Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis
NCT ID: NCT02936388
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2016-01-31
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
SIRT: Transarterial radioembolisation with Yttrium-90-bearing resin microspheres (SIR-Spheres®)
SIRT
catheter-based application of radioactive microspheres into the hepatic artery
Arm B
DSM-TACE: Transarterial chemoembolisation with Cisplatin and EmboCept® S starch microspheres (PharmaCept GmbH)
DSM-TACE
catheter-based application of chemotherapy and degradable starch microspheres into the hepatic artery
Interventions
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SIRT
catheter-based application of radioactive microspheres into the hepatic artery
DSM-TACE
catheter-based application of chemotherapy and degradable starch microspheres into the hepatic artery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Caroline Anna Peuker
MD
Principal Investigators
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Ulrich Keilholz, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Charité Universitätsmedizin Berlin, Charité Comprehensive Cancer Center (CCCC)
Locations
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Charité - University Medicine Berlin, Dept. of Haematology, Medical Oncology and Tumor Immunology, Campus Benjamin Franklin
Berlin, , Germany
Countries
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Related Links
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Other Identifiers
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SirTac2014
Identifier Type: -
Identifier Source: org_study_id
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