Patients with locally advanced resectable adenocarcinoma of the stomach or the esophagogastreal junction without previous therapy will be treated with one of two chemotherapy combinations before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others Epirubicin, Cisplatin and 5-FU (ECF). Main objective of the study is median overall survival.
714 Patients with locally advanced resectable (T2-4 and/or N+, M0) 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 overall survival, secondary endpoints are disease free survival, perioperative morbidity and mortality, histopathologic regression rate and R0-resection rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
716
2600 mg/m²d1 i.v. every 2 weeks
200 mg/m², d1, i.v., every 2 weeks
85 mg/m², d1, i.v., every 2 weeks
Krankenhaus Nordwest
Frankfurt, Germany
median overall survival
Time frame: 2 years follow-up
histopathological regression rate
Time frame: 6 weeks after surgery
disease free survival (DFS)
Time frame: 2 years follow-up
correlation of pCR and DFS with survival
Time frame: 2 years follow-up
Perioperative Morbidity and Mortality
Time frame: up to 2 months after surgery
R0-Resection rate
Time frame: 2 months after surgery
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50mg/m2, d1, i.v., every 2 weeks
50 mg/m2, d1, i.v., every 3 weeks
60 mg/m², d1, i.v., every 3 weeks
200 mg/m², d1-d21, i.v., every 3 weeks