NCT02936388

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
PROCEDURE	SIRT	catheter-based application of radioactive microspheres into the hepatic artery
PROCEDURE	DSM-TACE	catheter-based application of chemotherapy and degradable starch microspheres into the hepatic artery

Timeline

• Start date: 2016-01-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2016-10-18
• Last updated: 2025-01-24

Locations

1 site across 1 country: Germany