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

Phase 3 Recruiting 200 enrolled Krankenhaus Nordwest Deutsche Krebshilfe e.V., Bonn (Germany) · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2020-12-17
Primary completion: 2026-11-01
Completion: 2027-05-01

Publications

Gotze TO, Piso P, Lorenzen S, Bankstahl US, Pauligk C, Elshafei M, Amato G, Reim D, Bechstein WO, Konigsrainer A, Monig SP, Rau B, Schwarzbach M, Al-Batran SE. 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. BMC Cancer. 2021 Oct 29;21(1):1158. doi: 10.1186/s12885-021-08872-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	75 mg/m2	Other
Background	Docetaxel	Small molecule	50 mg/m2	Intravenous
Background	Leucovorin	Small molecule	200 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	85 mg/m2	Intravenous
Background	fluorouracil	Small molecule	2600 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications