RecruitingPhase 3NCT04447352

HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)

Preventive HIPEC in Combination With Perioperative FLOT Versus FLOT Alone for Resectable Diffuse Type Gastric and Gastroesophageal Junction Type II/III Adenocarcinoma - The Phase III "PREVENT" Trial of the AIO /CAOGI /ACO

Sponsor

Krankenhaus Nordwest

Enrollment

200 participants

Start Date

Dec 17, 2020

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Gastroesophageal Junction Adenocarcinoma

Summary

This is a multicenter, randomized, controlled, open-label study evaluating efficacy and safety of perioperative FLOT chemotherapy plus intraoperative HIPEC versus FLOT chemotherapy alone in patients with resectable localized and locally advanced diffuse and mixed type adenocarcinoma of the stomach and Type II/III GEJ.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a heated chemotherapy wash directly inside the abdomen (called HIPEC) during surgery, on top of standard chemotherapy (FLOT), improves survival for people with gastric (stomach) or gastroesophageal junction cancer. **You may be eligible if...** - You have been diagnosed with stomach or gastroesophageal junction adenocarcinoma (diffuse or mixed type) that can be surgically removed - You have received standard neoadjuvant FLOT chemotherapy before surgery - You are 18 or older and medically fit for surgery **You may NOT be eligible if...** - You did not receive pre-surgery chemotherapy, or received a different regimen than FLOT - You have a known allergy to 5-FU, leucovorin, oxaliplatin, or docetaxel - You have had prior abdominal surgery that would complicate this procedure - You are pregnant or breastfeeding 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

DRUG5-Fluorouracil

Day 1 q2w: 2600 mg/m² IV over 24 hours

DRUGLeucovorin

Day 1 q2w: 200 mg/m² IV over 30 minutes

DRUGOxaliplatin

Day 1 q2w: 85 mg/m² IV over 2 hours

DRUGDocetaxel

Day 1 q2w: 50 mg/m² IV over 1 hour

DRUGCisplatin

intraoperative: 75mg/m² intraabdominal solution over 1 hour and 30 minutes

Locations(15)

Uniklinik RWTH Aachen, AöR, Medizinische Klinik III, Studienzentrum Viszeralmedizin

Aachen, Germany

Universitätsklinikum, Klinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie

Dresden, Germany

Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany

Frankfurt, Germany

Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Viszerale, Gefäß- und Endokrine Chirurgie

Halle, Germany

Universitätsklinikum Leipzig, Klinik und Poliklinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie

Leipzig, Germany

Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Pneumologie, Diabetologie und Infektiologie

Ludwigsburg, Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Chirurgie

Lübeck, Germany

Universitätsklinikum Magdeburg

Magdeburg, Germany

Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Innere Medizin III

München, Germany

Universitätsklinikum Münster, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Münster, Germany

Krankenhaus Barmherzige Brüder Regensburg, Klinik für Onkologie und Hämatologie

Regensburg, Germany

Klinikum Südstadt Rostock, Klinik für Innere Medizin III

Rostock, Germany

Universitätsklinikum Tübingen, Universitätsklinik für Allgemeine, Viszeral- und Transplantationschirurgie Chirurgische Studienzentrale

Tübingen, Germany

Marien-Hospital Witten

Witten, Germany

Universitätsklinikum Würzburg, Chirurgische Klinik I, Chirurgisches Studienzentrum

Würzburg, Germany

View Full Details on ClinicalTrials.gov

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NCT04447352

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