Gastric cancer
Conditions
Interventions
None listed
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed malignancy for which treatment with 5-FU is indicated in the FLOT regimen. 2. Age >= 18 years 3. Patient is able and willing to give written informed consent 4. WHO performance status 0-2 5. Patient fulfills the general treatment criteria for treatment with FLOT including appropriate liver and renal function and other standard applicable laboratory values 6. Patient is able and willing to undergo extra blood sampling for 5-FU analysis
Exclusion criteria
Exclusion criteria: 1. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient*s safety. 2. Inability to undergo additional blood sampling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The population exposure of 5-FU in FLOT and the percentage of patients achieving 5-FU target AUC range. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Adverse effects - Correlation between needed dose reductions and 5-FU AUC - Intra-individual variation in 5-FU exposure between the different cycles - Inter-individual variation in 5-FU exposure | — |
Countries
Netherlands
Outcome results
None listed