Table 2.
Study schedule
| Visit no | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 |
| Visit name | Screening | C1D0 | C1D1 | C1D2 | C1D3 | C1D10 | C2D0 | C2D1 | C2D2 | C2D3 | C2D10 | C3D0 | C3D1 | C3D2 | C3D3 | C3D10 | CXD56* | Q3M |
| Scheduling window | −28 | −3 | ±3 | −3 | ±3 | ±3 | −3 | ±3 | ±3 | ±7 | ±14 | |||||||
| Patient information and consent | x | |||||||||||||||||
| Demographics | x | |||||||||||||||||
| Medical history | x | |||||||||||||||||
| Inclusion/exclusion criteria | x | |||||||||||||||||
| Physical examination† | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | |
| ECOG score | x | x | x | x | x | x | x | x | ||||||||||
| AE/SAE | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | |
| DLT evaluation‡ | x | |||||||||||||||||
| Concomitant medication | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | |
| Vital signs | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | |
| Haematology§ | x§ | x | x | x | x | x | x | x | ||||||||||
| Serum chemistry§ | x§ | x | x | x | x | x | x | x | ||||||||||
| Coagulation§ | x§ | |||||||||||||||||
| Serum tumour biomarker§ | x§ | x | x | x | ||||||||||||||
| Urine analysis§ | x§ | |||||||||||||||||
| Pregnancy test | (x)¶ | (x) | (x) | (x) | ||||||||||||||
| Chest CT | x | x | ||||||||||||||||
| CT enterography** (CT-PCI score) |
x | X†† | x | |||||||||||||||
| ECG | x | |||||||||||||||||
| Ascite volume | x | x | x | |||||||||||||||
| PIPAC | x | x | x | |||||||||||||||
| Surgical PCI score | x | x | x | |||||||||||||||
| Biopsies (standard and translational) | x | x | x | |||||||||||||||
| Blood sampling (translational research) | x | |||||||||||||||||
| PK (free plasmatic nab-paclitaxel)‡‡ | x | x | ||||||||||||||||
| QoL | x | x | x | x | x | x | x | |||||||||||
| VAS§§ | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | |
| Survival status | x | |||||||||||||||||
| Pathology and Molecular analysis | x | |||||||||||||||||
| Disease status | x |
*To be performed 56 days after the last PIPAC administration.
†Neurological examination with pallesthesia and abdominal circumference only requested at screening visit.
‡For dose-limiting toxicities, refer to study outcomes section.
§To be performed within 10 days prior to registration.
¶To be performed within 7 days prior to registration.
**When available.
††3 days before in order to assess the PCI score before the next administration.
‡‡Blood samples for pharmacokinetic analysis will be performed at the following time points: Predose 30 min (±5 min), end of infusion (±15 min), 1 hour (±15 min), 4 hours (±30 min), 24 hours (±4 hours). Samples collected at the first cycle of PIPAC for the two first patients treated for each dose level escalation.
§§Highest value of the day taken in bed.
AE, adverse event; DLT, dose-limiting toxicity; ECOG, Eastern Cooperative Oncology Group; PCI, Peritoneal Carcinomatosis Index; PIPAC, pressurised intraperitoneal aerosol chemotherapy; QoL, quality of life; SAE, serious AE; VAS, Visual Analogue Scale.