At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 151 enrolled
Drug / intervention
Yttrium 90 glass microspheresdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
TheraSphere for the Treatment of Liver Metastases: An Open Label Trial of TheraSphere in Patients With Liver Metastases From Primary Colorectal Cancer, Neuroendocrine Cancer or Non-colorectal/Non-neuroendocrine Cancer
In Brief
A Phase 2 clinical trial evaluating Yttrium 90 glass microspheres for Colorectal Cancer and 2 related conditions. Completed, enrolled 151 participants across 5 sites.
Detailed Summary
This study will evaluate Liver Progression Free Survival (PFS) and safety of TheraSphere treatment at doses of 120 Gy +/1 10% in patients at least 18 years of age diagnosed with metastatic disease to the liver that cannot be treated or is progressing following treatment with systemic or other liver-directed therapies.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsBTG International Inc.
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedAug 2007
Primary CompletionMar 2011
TodayJul 2026
First PostedAug 6, 2007
Enrollment StartJan 1, 2007
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 18.9 years ago
Interventions
Yttrium 90 glass microspheresdevice
120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe