RecruitingPhase 3NCT04597294

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


Sponsor

Jagiellonian University

Enrollment

600 participants

Start Date

Aug 1, 2021

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a heated chemotherapy wash of the abdominal cavity (called HIPEC) before standard stomach cancer surgery can reduce the risk of the cancer spreading to the peritoneum (the lining of the abdomen) — one of the most common and deadly sites of gastric cancer recurrence. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced gastric (stomach) cancer (T3 or T4 stage) with no distant organ spread - You are medically fit for surgery - You are eligible for standard perioperative chemotherapy (FLOT4) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You are over 75 years old - You have had prior major abdominal surgery (other than gallbladder or appendix removal) - You are pregnant or breastfeeding - You have another active cancer - You are not a candidate for chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTFLOT + HIPEC + Surgery

HIPEC with irinotecan after 4 doses of preoperative FLOT chemotherapy

COMBINATION_PRODUCTFLOT + Surgery

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


Locations(1)

Department of General, Oncological, Gastroenterological Surgery and Transplantology

Krakow, Lesser Poland Voivodship, Poland

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NCT04597294


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