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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00677144 | Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer | PHASE2 | COMPLETED | 88 | — | — | Apr 1, 2008 | Apr 1, 2012 | Oct 5, 2012 | 1 | South Korea |
| Arm | Type | Description |
|---|---|---|
| OS (oxalipaltin+S-1) | EXPERIMENTAL | OS (oxaliplatin + S-1): Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO \[BSA \<1.25 40mg bid (total 80mg/day); BSA ≥1.25 - \<1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)\], divided by two on D1-14 every 21 days |
| XELOX (oxalipaltin+capecitabine) | ACTIVE_COMPARATOR | XELOX (oxalipaltin+capecitabine): Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days |
| Name | Type | Description |
|---|---|---|
| OS (oxalipaltin+S-1) | DRUG | Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO \[BSA \<1.25 40mg bid (total 80mg/day); BSA ≥1.25 - \<1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)\], divided by two on D1-14 every 21 days |
| XELOX (oxalipaltin+capecitabine) | DRUG | Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days |
Inclusion Criteria: * Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred * Unresectable, locally advanced or metastatic * At least one uni-dimensional measurable lesion by RECIST criteria * Age 18 to 75 years old * Estimated life expectancy ≥3 months * ECOG performa...