Table 3.
Study procedures.
| Procedure | Screening visit (up to 28 days) |
Cycle 1-2-3 (28 days) |
C3D28 (–7 Days) |
Cycle 4-5-6 (28 days) |
Follow-up (C6D28) or ET | Follow-up (q3 months) | ||
|---|---|---|---|---|---|---|---|---|
| Preoperative |
Postoperative |
|||||||
| Day 1 | Day 15 | Day 1 | Day 15 | |||||
| Revision criteria INC/EXC | X | X (only C1D1) | X (only C4D1) | |||||
| Informed consent | X | |||||||
| Medical history | X | |||||||
| Demographics | X | |||||||
| Physical exam | X | Xc | Xc | Xc | Xc | X | ||
| Vital signs | X | Xc | Xc | Xc | Xc | X | ||
| KPS | X | Xc | Xc | Xc | Xc | X | ||
| CBC with differential | X | Xc | Xc | Xc | Xc | X | ||
| Serum chemistry | X | Xc | Xc | Xc | Xc | X | ||
| CA 19.9 | X | Xc | Xc | |||||
| Serum pregnancy testa | X | |||||||
| Urine pregnancy testa | X | X | X | |||||
| ECG | X | Xc (only C1) | Xc (only C1) | X | ||||
| Tumor assessment | X | X | X | |||||
| Concomitant medications | X | X | X | X | X | X | ||
| Concomitant procedures | X | X | X | X | X | X | ||
| Administration of nal-IRI, Oxaliplatin, 5-FU, leucovorin, including premedication | X | X | X | X | ||||
| Adverse event reportingb | X | X | X | X | X | X | ||
| Overall survival | X | |||||||
a
If indicated.
b
Healthcare professionals are asked to report any suspected drug adverse reactions.
c
Can be performed up to 3 days prior to drug.
CA, carbohydrate antigen; CBC, complete blood count; ECG, electrocardiogram; 5-FU, 5-fluorouracil; KPS, Karnofsky performance score; nal-IRI, nanoliposomal irinotecan; Oxa, oxaliplatin.