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Clinical Trials in Poland / NCT04597294
Recruiting Phase 3

Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence

NCT04597294 · tracked via the Priya Life Science Poland tracker
Sponsor
Jagiellonian University
Phase
Phase 3
Started
2021-08-01
Last updated
2024-03-06

Condition(s) studied

Gastric Cancer

Investigational drug(s) / intervention(s)

FLOT + HIPEC + SurgeryFLOT + Surgery

FLOT + HIPEC + Surgery: HIPEC with irinotecan after 4 doses of preoperative FLOT chemotherapy

FLOT + Surgery: Perioperative FLOT chemotherapy (4 doses before and 4 doses after gastrectomy) and surgery

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of General, Oncological, Gastroenterological Surgery and Transplantology Krakow Lesser Poland Voivodship Recruiting

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Other trials for the same condition

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 Recruiting
AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 Active, not recruiting
Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2 Recruiting
Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer Recruiting
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04597294 on ClinicalTrials.gov ↗ ← All trials in Poland