Perioperative Chemotherapy With FOLFIRINOX Regimen or FLOT Regimen for Resectable Gastric or Esophagogastric Junction Adenocarcinoma (Type II-III): Open-label Randomized Phase 2/3 Trial
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.
• сT4 cN0 or cT1-4 cN+ histologically proven adenocarcinoma of the esophagogastric junction (Siewert type II-III) or the stomach without distant metastases (M0)
• No previous cytostatic chemotherapy or radiation therapy
• Age 18-70 years (female and male)
• Eastern Cooperative Oncology Group ≤ 2
• Surgical resectability
• Neutrophils\> 2.000/µl
• Platelets \> 100.000/µl
• Normal value of Serum Creatinin
• Albumin level \> 29 г/л
⁃ Aspartate transaminase (AST) or alanine transaminase (ALT) less than 3 times the upper limits of normal (ULN)
⁃ Total Bilirubin less than 1.5 times the ULN
⁃ Written informed consent.