A more sustainable perioperative treatment regimen for gastroesophageal cancer —replacing 5-FU with capecitabine within the FLOT regimen
Key facts
- Where
- Rotterdam, HollandiaSee the site
- Phase
- 1. fázis
Where in Hollandia
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Trial code
- EU 2026-526209-13-00
- Record updated
- 2026. július 21.
- Original description
To determine the MTD and recommended dose of perioperative Capecitabine within the DOC regimen in oesophageal, GEJ and gastric adenocarcinoma patientsRead full original descriptionShow less
To determine the MTD and recommended dose of perioperative Capecitabine within the DOC regimen in oesophageal, GEJ and gastric adenocarcinoma patients
Inclusion: 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.
Exclusion: 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; 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); 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).