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A more sustainable perioperative treatment regimen for gastroesophageal cancer —replacing 5-FU with capecitabine within the FLOT regimen
EU CTIS ID: 2026-526209-13-00
What this study is testing
To determine the MTD and recommended dose of perioperative Capecitabine within the DOC regimen in oesophageal, GEJ and gastric adenocarcinoma patients
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- All routinely tested DPYD variants
- 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
- 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)
- Pregnant or lactating women
- Concomitant participation in any clinical study that could modify the outcomes relevant to this study
- Unwillingness or inability to comply with the study protocol
See the full eligibility criteria
- 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
- All routinely tested DPYD variants
- 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
- 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)
- Pregnant or lactating women
- Concomitant participation in any clinical study that could modify the outcomes relevant to this study
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.