Perioperative Chemotherapy in Gastric Cancer

• Status: Not yet recruiting
• Trial end date: 2029-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with resectable adenocarcinoma of the stomach or the esophagogastric 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 Oxaliplatin and Capecitabin (XELOX). Main objective of the study is histopathological regression rate.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ukrainian Society of Clinical Oncology
• Treatments: Capecitabine; Docetaxel; Fluorouracil; Leucovorin; Oxaliplatin

Criteria

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