Randomized Phase II Study of S-1 (SOX) or Capecitabine (XELOX) in Combination With Oxaliplatin in Patients With Recurrent or Metastatic Gastric Cancer
- To evaluate the time to progression in patients with recurrent or metastatic gastric
cancer treated with oxaliplatin in combination with S-1 vs capecitabine.
- To assess progression-free survival, overall response, disease-control rate,
time-to-treatment failure, response duration, time to response, overall survival,
safety, quality of life, pharmacogenetics, and psychologic distress/coping strategy.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral S-1 twice daily on days 1-14 and oxaliplatin IV over 2
hours on day 1.
- Arm II: Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin as
in arm I.
Courses in both arms repeat every 3 weeks in the absence of disease progression or
After completion of study treatment, patients are followed up every 2 months for 6 months.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Hyun C. Chung, MD, PhD