A more sustainable perioperative treatment regimen for gastroesophageal cancer —replacing 5-FU with capecitabine within the FLOT regimen

Prior treatment

• Any contra-indication for the (planned) FLOT regimen (e.g. active infection, serious concomitant disease, severe allergy, neurologic toxicity), as determined by the treating medical oncologist
• Concomitant participation in any clinical study that could modify the outcomes relevant to this study

Lab values

• Inadequate organ functions (defined as a hemoglobin <5.0 mmol/L (before transfusion), an absolute neutrophil count <1.5 x 109/l, platelet count <100 x 109/l, creatinine clearance <30 mL/min, bilirubin >2x ULN and liver transaminases >2.5x ULN)

Other

• All routinely tested DPYD variants
• Pregnant or lactating women
• Unwillingness or inability to comply with the study protocol
• Inability to take capecitabine tablets due to swallowing difficulties (i.e. dysphagia grade 3 or higher)
• Inability to receive a full dose of capecitabine/5-FU (e.g. due to impaired renal function or other clinically relevant contraindications or treatment-related toxicity)

• Histologically confirmed esophageal, GEJ, or gastric cancer with an indication for perioperative FLOT chemotherapy
• WHO-performance score of 0 to 1
• Aged 18 years or older
• Written informed consent according to the ICH-GCP and national/local regulations