Clinical trial · Interventional
Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
A Randomized, Multicenter Clinical Trial Comparing the Combination of Perioperative FLOT Chemotherapy and Preoperative Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Plus Gastrectomy to Perioperative FLOT Chemotherapy and Gastrectomy Alone in Patients With Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. The impact of treatment on peritoneal recurrence and survival over 6 months, 1, 3 and 5 years will be assessed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLOT + HIPEC + Surgery | Combination Product | — | UNRESOLVED |
| FLOT + Surgery | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Perioperative FLOT + prophylactic HIPEC + surgery
- description
- After 4 doses of preoperative FLOT chemotherapy diagnostic laparoscopy will be performed - patients without distant metastases will be randomised, in those randomised to experimental arm HIPEC with irinotecan will be performed (a dose of 300 mg/m2 body surface area will be administered over 45 minutes at a temperature of 42 degrees Celsius)
- interventionNames
- Combination Product: FLOT + HIPEC + Surgery
- type
- ACTIVE_COMPARATOR
- label
- Perioperative FLOT + surgery
- description
- Standard treatment regimen for advanced gastric cancer
- interventionNames
- Combination Product: FLOT + Surgery
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Gastric cancer confirmed histopathologically in tumor specimens. * Age 18-75 years. * Advanced gastric cancer cT3 / cT4a / N0-3b. * No distant metastases on computed tomography (CT) scan of the chest, abdomen and pelvis (cM0). * Written consent to participate in the study. Exclusion Criteria: * No clear histopathological confirmation of gastric cancer. * Age \> 75 years. * Poor general condition (Performance Status 3 or more on the Eastern Cooperative Oncology Group (ECOG)/World Health Organization scale). * Previous abdominal surgery (including oncological surgery), other than laparoscopic cholecystectomy or appendectomy (open or laparoscopic). * Pregnancy and lactation. * Refusal to participate or an inability to provide written consent. * Coexisting cancer in another location. * Systemic treatment or radiotherapy for another cancer. * Dysphagia requiring surgical treatment (gastric resection or nutritional jejunostomy) before starting neoadjuvant treatment and indication for accelerated surgery for other reasons. * Disqualification for perioperative FLOT4 chemotherapy as decided by a multi-specialist consultation.
References
Publications (0)
Data not yet available