Phase 2 Study of Preoperative Chemotherapy Using Docetaxel, Oxaliplatin, and S-1 for Patients With Unresectable Locally Advanced or Lymph Node Metastatic Gastric Cancer

What this Trial Is About

Gastric cancer is a common and deadly cancer worldwide, particularly in Korea, where it is a leading cause of cancer death. Surgery to remove the cancer completely is the main cure, but many patients cannot have this due to local spread or distant lymph node involvement. This research evaluates a combination chemotherapy before surgery, called neoadjuvant chemotherapy, to improve outcomes by shrinking tumors, treating early spread, and avoiding unnecessary surgeries in patients with advanced or metastatic gastric cancer limited to lymph nodes. The trial studies the use of three chemotherapy drugs docetaxel and oxaliplatin given intravenously every three weeks, and S-1 taken orally twice daily for two weeks, repeated in cycles. This treatment is given before surgery in patients whose cancers are locally advanced or have distant metastases limited to lymph nodes, aiming to improve the rate of complete tumor removal R0 resection. The study is a phase 2 clinical trial assessing safety and effectiveness of this chemotherapy combination in this patient group. Participants will be monitored for tumor removal success one year after chemotherapy. Throughout the trial, patients will undergo physical exams, imaging scans, laboratory tests, and assessments of organ function to track treatment safety and cancer response. Researchers also measure survival times and biological markers. The study includes careful follow-up to evaluate treatment outcomes and side effects, with total participation lasting through preoperative chemotherapy and at least one year for surgery outcomes.

A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer