Stomach Neoplasms Clinical Trial
Official title:
A Randomized Phase II Study of S-1 Versus Capecitabine as First-Line Chemotherapy in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer
This study is an open-label, single-center, and randomized phase II study designed to
evaluate each efficacy and safety of S-1 and capecitabine in the elderly and/or poor
performance status patients with recurrent or metastatic gastric cancer. The randomization
will be stratified by age (70-85 years versus 65 years and < 70 years) and performance
status, which is dependent on age group; in 70-85 years, ECOG performance status 0-1 versus
2 and in ³65 years and <70 years, ECOG performance status 2 versus 3.
- S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)
- Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning) Treatment
will be administered every 3 weeks and will be continued in the absence of disease
progression or unacceptable toxicity.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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