NCT04447352 (PREVENT) is a Phase 3 clinical trial of 5-Fluorouracil in Gastric Cancer, sponsored by Krankenhaus Nordwest.

Who is sponsoring NCT04447352?

NCT04447352 is sponsored by Krankenhaus Nordwest.

What drugs are being tested in NCT04447352?

Interventions in NCT04447352: 5-Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel, Cisplatin.

What condition does NCT04447352 study?

NCT04447352 studies Gastric Cancer, Gastroesophageal Junction Adenocarcinoma.

Is NCT04447352 still recruiting?

NCT04447352 is currently recruiting now. Last updated 12 November 2024.

Last reviewed 2024-11-12 · How we verify

NCT04447352: PREVENT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 12 November 2024

What this trial tests

Phase 3 trial testing 5-Fluorouracil in Gastric Cancer in 200 participants. Currently enrolling.

Timeline

17 December 2020

Primary endpoint
1 November 2026

1 May 2027

Quick facts

Lead sponsor	Krankenhaus Nordwest
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	17 December 2020
Primary completion	1 November 2026
Estimated completion	1 May 2027
Sites	15 locations across Germany

Drugs / interventions tested

5-Fluorouracil
Leucovorin (leucovorin) — full drug profile →
Oxaliplatin (Oxaliplatin) — full drug profile →
Docetaxel (Docetaxel) — full drug profile →
Cisplatin (cisplatin) — full drug profile →

Conditions studied

Gastric Cancer — all drugs for Gastric Cancer →
Gastroesophageal Junction Adenocarcinoma — all drugs for Gastroesophageal Junction Adenocarcinoma →

Sponsor

Krankenhaus Nordwest — full company profile →

Who can join

Adults 18 to 75, any sex, with Gastric Cancer or Gastroesophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

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"- (FLOT9) trial of the AIO /CAOGI /ACO.
Götze TO, Piso P, Lorenzen S, Bankstahl US, et al · · 2021 · cited 38× · PMID 34715810 · DOI 10.1186/s12885-021-08872-8
Gastric Cancer With Peritoneal Metastasis-A Comprehensive Review of Current Intraperitoneal Treatment Modalities.
Prabhu A, Mishra D, Brandl A, Yonemura Y. · · 2022 · cited 27× · PMID 35719946 · DOI 10.3389/fonc.2022.864647
Poorly cohesive cells gastric carcinoma including signet-ring cell cancer: Updated review of definition, classification and therapeutic management.
Drubay V, Nuytens F, Renaud F, Adenis A, et al · · 2022 · cited 23× · PMID 36160745 · DOI 10.4251/wjgo.v14.i8.1406
Effect of hyperthermic intraperitoneal chemotherapy on survival and recurrence rates in advanced gastric cancer: a systematic review and meta-analysis.
Patel M, Arora A, Mukherjee D, Mukherjee S. · · 2023 · cited 17× · PMID 37158149 · DOI 10.1097/js9.0000000000000457
Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery for gastric carcinoma at high risk of peritoneal carcinomatosis: short and long-term outcomes (GOETH STUDY)-a collaborative randomized controlled trial by ACOI, FONDAZIONE AIOM
Di Giorgio A, Gerardi C, Abatini C, Melotti G, et al · · 2022 · cited 11× · PMID 36457115 · DOI 10.1186/s13063-022-06880-y
Hyperthermic intraperitoneal chemotherapy (HIPEC) plus systemic chemotherapy versus systemic chemotherapy alone in locally advanced gastric cancer after D2 radical resection: a randomized-controlled study.
Yu P, Huang X, Huang L, Dai G, et al · · 2023 · cited 9× · PMID 37392201 · DOI 10.1007/s00432-023-05019-z
Gastric Cancer (GC) with Peritoneal Metastases (PMs): An Overview of Italian PSM Oncoteam Evidence and Study Purposes.
Sammartino P, De Manzoni G, Marano L, Marrelli D, et al · · 2023 · cited 8× · PMID 37370747 · DOI 10.3390/cancers15123137
Update of randomized controlled trials evaluating cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in prevention and therapy of peritoneal metastasis: a systematic review.
Noiret B, Piessen G, Eveno C. · · 2022 · cited 8× · PMID 35812007 · DOI 10.1515/pp-2021-0152

Verify or expand the search:

Other trials of 5-Fluorouracil

Trials testing the same drug.

NCT07419464 — 5-Fluorouracil Response and Optimization STudy (The FROST Trial) · Phase 2 · not yet recruiting
NCT07059611 — Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma · Phase 2 · not yet recruiting
NCT07441369 — Abemaciclib Combined With FOLFOX/FOLFIRI Regimen in Patients With Advanced Colorectal Liver Metastases Cancer · Phase 2 · enrolling by invitation
NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta · Phase 3 · recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting

Other recruiting trials for Gastric Cancer

Currently open trials in the same condition.

NCT07525765 — AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer · recruiting
NCT07464470 — Comparison of Molecular-Genetic Concordance of the Primary Tumor and Brain Metastases of Gastroesophageal Cancers · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07431281 — Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Meta · Phase 3 · recruiting
NCT07448493 — Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer · active not recruiting

Other Krankenhaus Nordwest trials

Trials by the same sponsor.

NCT03673072 — Neoadjuvant Chemotherapy With Gemcitabine Plus Cisplatin Followed by Radical Liver Resection Versus Immediate Radical Li · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04447352 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Krankenhaus Nordwest
Last refreshed: 12 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04447352.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing