Randomized Study Comparing Perioperative FLOT and Adjuvant XELOX Chemotherapy With Surgery for Advanced Stomach and Esophagogastric Junction Cancer

What this Trial Is About

Researchers are evaluating the use of perioperative FLOT chemotherapy compared to adjuvant XELOX chemotherapy for patients with locally advanced stomach and esophagogastric junction cancers. This randomized controlled trial focuses on patients with operable clinical stage T3 or higher and N1 or higher disease. The primary goal is to compare 3-year disease-free survival between these two treatment approaches, addressing the current gap in prospective comparative data. Participants are randomly assigned to one of two treatment groups. In the FLOT group, patients receive four cycles of chemotherapy with Docetaxel, 5-FU, Leucovorin, and Oxaliplatin every two weeks before surgery, followed by radical gastrectomy, and then four additional cycles of the same chemotherapy after surgery. Granulocyte colony stimulating factor is recommended during chemotherapy. In the XELOX group, patients undergo surgery first, followed by eight cycles of chemotherapy with Capecitabine and Oxaliplatin. Surgery is scheduled approximately four weeks after preoperative chemotherapy in the FLOT group. During the study, participants undergo assessments including endoscopy and CT scans to evaluate tumor status before surgery. Researchers monitor survival outcomes, chemotherapy and surgery adverse events, chemotherapy completion rates, postoperative hospital stay, cancer recurrence, and tumor regression grade. The total follow-up for primary outcome measurement is three years, with some secondary outcomes assessed up to five years. This trial aims to provide evidence on optimal chemotherapy timing and regimen for locally advanced stomach cancer patients.

Perioperative FLOT vs Adjuvant XELOX for CA Stomach