Table 1:
Study period | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Enrollment | Allocation | Postallocation | Follow-up | ||||||||||
Time point | Preoperative | 0 week | 1 week | 2 weeks | 3 weeks | 5 weeks | 6 weeks | 7 weeks | 9 weeks | 10 weeks | 11 weeks | 17 weeks | 35 weeks |
Enrollment | |||||||||||||
Eligibility screen | x | ||||||||||||
Informed consent | x | ||||||||||||
Allocation | x | ||||||||||||
Interventions | |||||||||||||
PIPAC 1 | x | ||||||||||||
PIPAC 2 | x | ||||||||||||
PIPAC 3 | x | ||||||||||||
Assessments | |||||||||||||
Blood sampling for toxicity | x | x | x | x | |||||||||
Blood sampling for PK modelling | x | x | x | ||||||||||
Tumor biopsies for PK modelling | x | x | x | ||||||||||
Blood sampling for PD modelling | x | x | x | x | x | x | x | ||||||
Quality of life | x | x | x | x | x | x | |||||||
Pain score | x | x | x | x | x | x | x |