Gastric cancer
Conditions
Brief summary
The MTD will be established using a 3+3 dose escalation design in which the amount of DLTs will determine the MTD
Detailed description
Safety of the administered treatment, assessed by: - All treatment-related adverse events (AEs) according to CTCAE; - All serious adverse events (SAEs); - All postoperative complications, Percentage of patients discontinuing treatment due to treatment-related adverse events • Percentage of patients getting to resection after preoperative chemotherapy, Assessed by the pharmacokinetic parameters and peritoneum/plasma ratio during the second treatment cycle, Assessed by comparing UGT1A1 genotype and pharmacokinetic parameters in the peritoneal cavity
Interventions
Sponsors
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The MTD will be established using a 3+3 dose escalation design in which the amount of DLTs will determine the MTD | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of the administered treatment, assessed by: - All treatment-related adverse events (AEs) according to CTCAE; - All serious adverse events (SAEs); - All postoperative complications, Percentage of patients discontinuing treatment due to treatment-related adverse events • Percentage of patients getting to resection after preoperative chemotherapy, Assessed by the pharmacokinetic parameters and peritoneum/plasma ratio during the second treatment cycle, Assessed by comparing UGT1A1 genotype and pharmacokinetic parameters in the peritoneal cavity | — |
Outcome results
None listed