NCT02936388CompletedPhase 2
Transarterial Radioembolisation in Comparison to Transarterial Chemoembolisation in Uveal Melanoma Liver Metastasis
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
Source: ClinicalTrials.gov · Last updated 24 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 108 (actual)
- First submitted
- 9 Sept 2016
- Start date
- 1 Jan 2016
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Melanoma
- NCT number
- NCT02936388
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 108
- From 1 Jan 2016 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous intraarterial hepatic treatment (e.g. radioembolisation, chemoembolisation, intraarterial chemotherapy, isolated or percutaneous hepatic perfusion)
- Previous treatment with external liver radiation
- Current treatment with any anti-cancer therapy
Other illness
- 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
Other
- Surgically treatable liver metastases
- Major intrahepatic occlusion of the portal vein and/or tumor infiltration of the portal vein
- Liver cirrhosis Child-Pugh C
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charité - University Medicine Berlin, Dept. of Haematology, Medical Oncology and Tumor Immunology, Campus Benjamin Franklin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.