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
Jagiellonian University
600 participants
Aug 1, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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.
Interventions
HIPEC with irinotecan after 4 doses of preoperative FLOT chemotherapy
Perioperative FLOT chemotherapy (4 doses before and 4 doses after gastrectomy) and surgery
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04597294