Peri-operative intraperitoneal irinotecan and systemic FLOT in the curative treatment of gastric cancer and gastroesophageal junction cancer: a phase I study
Key facts
- Where
- Eindhoven és Rotterdam, HollandiaSee the 2 sites
- Phase
- 1. fázis
Where in Hollandia
- Catharina Ziekenhuis StichtingEindhoven, HollandiaTaking people
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaTaking people
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 2025-522864-34-00
- Record updated
- 2026. március 16.
- Original description
To determine the MTD and recommended phase II dose of perioperative CBIP irinotecan combined with systemic FLOT in gastric cancer or gastroesophageal junction cancer patients undergoing gastrectomyRead full original descriptionShow less
To determine the MTD and recommended phase II dose of perioperative CBIP irinotecan combined with systemic FLOT in gastric cancer or gastroesophageal junction cancer patients undergoing gastrectomy
Inclusion: Histologically confirmed GC or GEJ adenocarcinoma planned to (sub)total gastrectomy in combination with perioperative systemic FLOT chemotherapy; WHO-performance score 0 -1 with a life expectancy greater than or equal to three months; Aged 18 years or older; Written informed consent according to the ICH-GCP and national/local regulations.
Exclusion: Any contra-indication for the (planned) systemic chemotherapy (e.g. active infection, serious concomitant disease, severe allergy, persistent neurologic toxicity after (neo-)adjuvant oxaliplatin based systemic therapy), 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); Pregnant or lactating women; Unwillingness or inability to comply with the study protocol.