Visit1 | Screening | Chemotherapy period | Follow-up period | |||
---|---|---|---|---|---|---|
C1D1 | C2–3D1 C5–7D1 C9–11D1 | C4D1 C8D1 C12D1 | F1–5 | F6, F7 | ||
Interval | 2 weeks (-4 d/+7 d) | 4 months (-14/+30 d) | 6 months (-14/+30 d) | |||
Informed consent | X | |||||
Screening number | X | |||||
Complication check2 | X | |||||
Criteria check | X | X | ||||
Randomization | X | |||||
Performance status check | X | X | X | X | ||
Medical history and physical examination | X | X | X | X | X | X |
Height, weight, BSA3 | X | X | X | |||
Vital sign4 | X | X | X | X | ||
Laboratory test5 | X | X | X | X | X | X |
Pregnancy test 6 | X | X (even-numbered cycles) | ||||
Treatment | X | X | X | |||
CEA7 | X | X | X | X | ||
Imaging study8 | X | X | X | |||
Colonoscopy9 | X | X | ||||
Safety assessment | X | X | X | |||
Efficacy assessment | X | X | X |