Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00511862 | TheraSphere for the Treatment of Liver Metastases | PHASE2 | COMPLETED | 151 | — | — | Jan 1, 2007 | Mar 1, 2011 | May 13, 2021 | 5 | United States |
Progression per RECIST v 1.0 is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as the reference the smallest sum of longest diameters recorded since treatment started, or unequivocal progression of existing non-target lesion or appearance of new lesions. A maximum of 5 target lesions per organ are assessed. To assess the impact of a non-systemic local therapy on progression, for the purposes of this trial, hepatic progression was defined as at least a 20% increase in the sum of the longest diameter of target hepatic lesions. Hepatic progression-free survival is the time from the day of first treatment with TheraSphere to determination of hepatic progression.
| Arm | Type | Description |
|---|---|---|
| TheraSphere | EXPERIMENTAL | Single arm, TheraSphere Yttrium 90 glass microspheres at 120 Gy +/- 10%; stratified by type of disease (colorectal cancer, neuroendocrine cancer, non-colorectal/non-neuroendocrine cancer |
| Name | Type | Description |
|---|---|---|
| Yttrium 90 glass microspheres | DEVICE | 120 Gy unilobar or bilobar infusion with the second infusion occurring 3-7 weeks following treatment of the first lobe |
Inclusion Criteria: * 18 years of age or older * diagnosis of metastatic disease to the liver that is refractory to, or inappropriate for, other systemic or liver-directed therapies * unresectable liver metastases * target tumors measurable using standard imaging techniques * tumor replacement \< o...