NCT01473004|CompletedPhase 2ResultsDMCFDA Device
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An Open-Label, Single Institution, Phase II Study Using Radioactive Yttrium90 Microsphere (SIR-Sphere®) in Uveal Melanoma Patients With Hepatic Metastasis
Sponsor study identifier
Secondary identifiers
OTHER · JeffTrial Number
interventional
48
1 country
1
Study Start
October 31, 2011
Actual (reported)Primary Completion
July 7, 2022
Actual (reported)Study Completion
December 31, 2024
Actual (reported)The purpose of this study is to determine whether radiation provided locally to the liver tumor vasculature environment will demonstrate a response of tumor decline. This radiation may cause the tumor cells to die. This is a phase II clinical trial to investigate safety and efficacy of radioactive microsphere (SIR-Spheres® microspheres). Uveal melanoma patients with progressing hepatic metastases who received no more than one intra-hepatic arterial treatment will be enrolled. Patients will be first stratified into two groups: Group A, no prior intra-hepatic arterial treatment; Group B, one prior intra-hepatic arterial treatment).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 31, 2011
Actual (reported)November 14, 2011
Actual (reported)November 17, 2011
Actual (reported)July 7, 2022
Actual (reported)December 31, 2024
Actual (reported)November 14, 2025
Actual (reported)Clinical Benefit Rate of Previously Treated and Naive Patients
Evaluation of clinical benefit includes status of complete and partial response as well as stable disease
3 months post final treatment, an average of 4 months
Number of Patients With Adverse Events
Adverse events except for baseline symptoms will be collected from start of first treatment to 3 months post final treatment
3 months post final treatment, an average of 4 months
Overall Survival
From date of first SIR-Spheres® administration until the date of death from any cause, assessed up to 6 years
Progression Free Survival
2 years post treatment, an average of 10 months
Duration of Response
2 years post treatment, an average of 10 months
Patients with no prior intra-hepatic arterial treatment will be treated with intra-hepatic arterial infusion of Yttrium-90 radioactive microspheres (SIR-Spheres® microspheres). Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.
Patients with one prior hepatic trans-arterial embolization treatment will be treated with intra-hepatic arterial infusion of Yttrium-90 radioactive microspheres (SIR-Spheres® microspheres). Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.
Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Takami Sato, MD
Thomas Jefferson University
Carin Gonsalves, MD
Thomas Jefferson University
48 participants (actual enrollment reported by the registry).
First Submitted
November 14, 2011
First Posted
November 17, 2011
Study Start
October 31, 2011
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 7, 2022
Actual (reported)Study Completion
December 31, 2024
Actual (reported)Last Updated
November 14, 2025
Results First Posted
November 14, 2025
Record last verified: 2025-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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