Table 2:
Study schedule.
Assessment | Screening | PIPAC 1 | F/U for AE | PIPAC 2 | F/U for AE | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Week | 1 | 3 | 6 | 7 | 9 | 12 | |||||||
Day no. | −28 to 0 | 1 | 2 | 3 | 4 | 15 | 36 | 43 | 44 | 45 | 46 | 57 | 78 |
Informed consent | □ | ||||||||||||
Medical history and demographic | □ | ||||||||||||
Clinico-surgical findings | □ | □ | |||||||||||
Physical examination | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ |
Vital signs (height at screening only) | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ |
Performance status | □ | □ | |||||||||||
12-lead ECG | □ | ||||||||||||
FBC | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ |
Biochemistry | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ |
Pharmacokinetic assessment | □ | □ | □ | □ | |||||||||
Ascites/peritoneal washing | □ | □ | □ | ||||||||||
Serum or urine pregnancy test | □ | ||||||||||||
Clinical toxicity assessments | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | □ | |
EORTC QLQ-C30 | □ | □ | □ | ||||||||||
CT imaging | □ | □ | □ |