Patients with resectable adenocarcinoma of the stomach or the esophagogastric junction (II-III type by Siewert) 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 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX). Main objective of the study is median overall survival.
538 Patients with resectable (cT4cN0 or cT1-4 and cN+, cM0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After randomization patients receive perioperatively 4 cycles FLOT or FOLFIRINOX, followed by a restaging of the tumour status and surgery. Subsequently another 4 cycles of FLOT or FOLFIRNOX are applicated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
538
d1 Irinotecan 180mg/m² every two weeks
d1-2 5-FU 2450 mg/m² every two weeks
d1 Leucovorin 200 mg/m² every two weeks
d1 Oxaliplatin 85 mg/m² every two weeks
d1 Docetaxel 50mg/m2 every two weeks
Aleksei Kalinin
Moscow, Russia
RECRUITINGmedian overall survival
Time frame: 2 years
Pathologic complete response rate
Time frame: 1 month after surgery
Disease free survival
Time frame: 2 years
Perioperative Morbidity and Mortality
Time frame: 1 months after surgery
R0-Resection rate
Time frame: 1 month after surgery
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