Perioperative Chemotherapy in Gastric Cancer

Treatment Discontinuation Associated With Perioperative Toxicity of FLOT Versus XELOX Chemotherapy in Patient With Resectable Gastric Cancer; Phase 2

Patients with resectable adenocarcinoma of stomach or esophagogastric junction without previous therapy will be treated with one of two chemotherapy regimens perioperatively. One group of the patients will receive 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the second group will receive Oxaliplatin and Capecitabin (XELOX). Primary endpoint of the study is the proportion of patients who complete all allocated treatment.

328 рatients with resectable (T1b-4 and/or N-/+, M0) adenocarcinoma of the stomach or the esophagogastric junction without previous therapy will be included in this study. After staging laparocopy patients will be randomized to receive preoperatively 4 cycles FLOT or 4 cycles XELOX followed by curative surgery. Adjuvant chemotherapy will be given as 4 cycles of FLOT or 4 cycles XELOX. The primary endpoint is the proportion of patients who fully adhered to all the allocated treatment per protocol. Secondary endpoints are pathological regression grade, progression free survival, overall survival, chemotherapy and surgery complications rates.

Inclusion Criteria:

• cT1b-T4b (cT4b - invasion in diaphragm, parenchyma of liver, spleen, pancreas, abdominal wall, small bowel, colon, distal part of splenic artery)
• cN0-3
• M0
• Age: 18 - 80
• ECOG: 0 - 1
• Histological type: adenocarcinoma
• Differentiation grade: G0 - G4
• No previous surgery
• No previous chemotherapy
• No concomitant severe comorbidity
• Written informed consent

Exclusion Criteria:

• cT1a, cT4b (invasion in truncus, hepatic artery, proximal part of splenic artery)
• Presense of distant metastases
• ECOG: 2 - 5
• Age: <18 and >80
• Severe concomitant comorbidity