Total Neoadjuvant Chemotherapy With 5-fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel in Locally Advanced Gastric and Gastroesophageal Junction Cancer (OCTASUR): Randomized, Multi-center, Open-label Trial

What this Trial Is About

Researchers are evaluating two chemotherapy approaches for patients with locally advanced gastric and gastroesophageal adenocarcinoma who have not received cancer treatment in the last five years. This randomized, multi-center European trial compares completing all planned chemotherapy cycles and surgery between two groups. The study focuses on understanding which regimen patients tolerate better and how these treatments affect survival, quality of life, tumor response, and microbiome changes. Participants will be randomly assigned to one of two groups. One group receives eight total cycles of FLOT chemotherapy before surgery (total neoadjuvant therapy). The other group receives four cycles of FLOT chemotherapy before surgery and four cycles after surgery (perioperative chemotherapy). The FLOT regimen includes the drugs 5-Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel given intravenously every two weeks. Surgery follows chemotherapy in both groups. The study aims to enroll 150 patients and monitors treatment tolerance and complications. During the study, participants will undergo diagnostic laparoscopy before randomization. Researchers will monitor chemotherapy side effects, surgical complications, tumor response, quality of life for 24 months, and overall survival up to five years. Biomarkers such as pathohistological response and gut microbiome composition will also be assessed. The primary outcome is the completion rate of all eight planned chemotherapy cycles and surgery, measured over 12 weeks from enrollment to treatment end.

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