Phase 3 Study Comparing Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 as Adjuvant Chemotherapy for Stage III Gastric Cancer After D2 Gastrectomy

What this Trial Is About

Researchers are evaluating adjuvant chemotherapy for patients with stage III gastric cancer who have undergone D2 gastrectomy and achieved R0 resection. This phase 3, open-label, randomized study compares the effects of oxaliplatin plus S-1 versus docetaxel plus S-1 on disease-free survival. The study aims to provide direct comparison of these two chemotherapy regimens, focusing on their safety profiles, treatment duration, and patient adherence. Participants are randomly assigned to one of two treatment groups. The first group receives eight 3-week cycles of intravenous oxaliplatin with oral S-1 doses adjusted by body surface area. The second group receives oral S-1 for the first cycle, followed by six cycles of intravenous docetaxel plus oral S-1, and then continues oral S-1 for up to one year. The treatments are given after surgery, and the study includes follow-up for five years. During the study, participants undergo monitoring for disease recurrence and overall survival, along with safety assessments over approximately six months of treatment. The main outcome measured is the 3-year disease-free survival rate, with secondary outcomes including 5-year overall survival, safety profiles, and recurrence sites. The study will track patients closely with regular evaluations throughout the treatment and follow-up periods.

Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer