2025-522864-34-00RecruitingPhase 1
Peri-operative intraperitoneal irinotecan and systemic FLOT in the curative treatment of gastric cancer and gastroesophageal junction cancer: a phase I study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- 30 Mar 2026
- Lead sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Diseases
- Gastric and esophageal cancer
- EU CT number
- 2025-522864-34-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with gastric cancer or cancer of the gastroesophageal junction who are planned to have stomach removal surgery together with FLOT chemotherapy around the operation.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Adenocarcinoma of the stomach or gastroesophageal junction, confirmed by tissue examination, planned for total or subtotal gastrectomy with FLOT chemotherapy before and after surgery.
- Earlier treatment
- Persistent nerve damage after earlier oxaliplatin-based chemotherapy is a reason not to join. Otherwise no prior treatment is required.
Main reasons for not taking part
- Any reason the treating oncologist judges that the planned chemotherapy cannot be given (for example active infection, serious other disease, severe allergy)
- Organ function too poor, based on blood counts, kidney function and liver tests
- Pregnant or breastfeeding women
- Taking part in another clinical study that could change the results of this one
- Unwilling or unable to follow the trial plan
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
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
- Pregnant or lactating women
- Unwillingness or inability to comply with the study protocol.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Catharina Ziekenhuis Stichting | Eindhoven | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.