Trial | Analyzed patients | Schedule | End point | |||||
---|---|---|---|---|---|---|---|---|
Name | Phase | Year | Total | Per arm | Regimen | Drug and dose | primary | secondary |
ACCORD12/0405-Prodige 2 | III | 2010 | 584 | 291 | OXP-5FU CRT | Cap 1600 mg/mq daily + OXP 50 mg/mq weekly | pCR | CRM, SP, LC,PFS |
293 | 5FU CRT | Cap 1600 mg/mq daily | ||||||
NSAPB R-04 | III | 2005 | 1284 | 643 | OXP-5FU CRT | 5FU 225 mg/mq daily or Cap 1650 mg/mq daily + OXP 50 mg/mq weekly | LRC | OS, DFS, TLRR |
641 | 5FU CRT | 5FU 225 mg/mq daily or Cap 1650 mg/mq daily | ||||||
CAO/ARO/AIO-04 | III | 2006 | 1236 | 613 | OXP-5FU CRT | 5FU 250 mg/mq days 1–14 and 22–35 + OXP 50 mg/mq on days 1,8,22,29 | DFS | |
623 | 5FU CRT | 5FU 1000 mg/mq days 1–5 and 29–33 | ||||||
Chinese study | III | 2007 | 206 | 103 | OXP-5FU CRT | Cap 1600 mg/mq days 1–14 and 22–25 + OXP 60 mg/mq on days 1,8,22,29 | DFS, OS | |
103 | 5FU CRT | Cap 1600 mg/mq days 1–14 and 22–25 |