Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FOLFOXIRI+ Bevacizumab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Control | ACTIVE_COMPARATOR | modified FOLFOX6 + bevacizumab |
| Experimental | EXPERIMENTAL | FOLFOXIRI+bevacizumab |
| Name | Type | Description |
|---|---|---|
| modified FOLFOX6 + bevacizumab | DRUG | * Bevacizumab 5 mg/kg iv, day 1, followed by * Oxaliplatin 85 mg/m2 iv administered over a period of 2 hours, day 1, followed by * 5- Fluorouracil (FU)/Leucovorin (LV), day 1 and 2, as follow: * LV 400 mg/m2 iv administered over a period of 2 hours, followed by * 5-FU 400 mg/m2 iv bolus, followed by * 5-FU 2.400 mg/m2 over 46 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle). |
| FOLFOXIRI + Bevacizumab | DRUG | * Bevacizumab 5 mg/kg iv, followed by * Irinotecan 165 mg/m2 iv administered over a period of 30-90 minutes, followed by * Oxaliplatin 85 mg/m2 iv administered over a period of 2 hours, followed by * LV 400 mg/m2 iv administered over a period of 2 hours, followed by * 5-FU 3,200 mg/m2 for 48 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle). |
Inclusion Criteria: 1. Patient's Informed consent in written. 2. Age between 18 and 70 years old. 3. Eastern Cooperative Oncology group performance status (ECOG) 0-1. 4. Life expectancy of at least 3 months. 5. Histological confirmation of adenocarcinoma of the colon or rectum. 6. To be included in...
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