Total Neoadjuvant FLOT Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer

The main goal of this study is to investigate the proportion of participants with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment during the last 5 years who can tolerate all planned cycles of chemotherapy and radical surgical treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery: 1. 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin, and Docetaxel (FLOT) followed by surgery. 2. 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.

NCT Number	NCT06028737
Lead Sponsor	Ukrainian Society of Clinical Oncology
Conditions	Gastric Cancer, Stomach Cancer, GastroEsophageal Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Advanced Gastric Adenocarcinoma, Gastric Neoplasm, Stomach Neoplasm +8 more
Enrollment	150 participants
Start Date	2025-03-25
Primary Completion	2027-04-25 (estimated)
Study Completion	2032-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-06