A Randomized Multicenter Phase II/III Study Comparing 5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced Resectable Adenocarcinoma of the Esophagogastreal Junction or the Stomach
590 Patients with locally advanced resectable (T2-4 and/or N+, M10) adenocarcinoma of the
stomach or the esophagogastreal junction without previous therapy will be included in this
study. After randomization patients receive perioperatively 4 cycles FLOT or 3 cycles ECF,
followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of
FLOT or 3 cycles ECF are applicated. Then a central validation of the pathological remission
rate is scheduled. Primary endpoint is disease free survival, secondary endpoints are
overall survival,perioperative morbidity and mortality, histopathologic regression rate and
R0-resection rate.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free survival
2 years follow-up
No
Salah-Eddin Al-Batran, MD
Principal Investigator
Krankenhaus Nordwest
Germany: Federal Institute for Drugs and Medical Devices
FLOT4
NCT01216644
July 2010
December 2015
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