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OncoMatch/Clinical Trials/NCT04447352

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

Is NCT04447352 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for gastric cancer.

Phase 3RecruitingKrankenhaus NordwestNCT04447352Data as of May 2026

Treatment: 5-Fluorouracil · Leucovorin · Oxaliplatin · Docetaxel · CisplatinThis 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.

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Extracted eligibility criteria

Cancer type

Gastric Cancer

Esophageal Carcinoma

Disease stage

Required: Stage UT3, UT4A, ANY T N+ M0

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: FLOT chemotherapy (5-FU, leucovorin, oxaliplatin, docetaxel) — neoadjuvant

Patient has received 3 to 6 cycles of neoadjuvant FLOT (de-escalation or dose modification allowed)

Cannot have received: cytotoxic or targeted therapy

Exception: other than neoadjuvant FLOT (including de-escalated or dose reduced schema) therapy

No preceding cytotoxic or targeted therapy other than neoadjuvant FLOT (including de-escalated or dose reduced schema) therapy

Cannot have received: tumor resection

No prior partial or complete tumor resection

Lab requirements

Blood counts

adequate to allow surgical procedure and hipec at investigator´s discretion

Kidney function

adequate to allow surgical procedure and hipec at investigator´s discretion

Liver function

adequate to allow surgical procedure and hipec at investigator´s discretion

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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