Gastric Cancer Clinical Trial
Official title:
Randomized Phase II Study of S-1 (SOX) or Capecitabine (XELOX) in Combination With Oxaliplatin in Patients With Recurrent or Metastatic Gastric Cancer
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, S-1, and capecitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor
cells. It is not yet known whether giving oxaliplatin together with S-1 is more effective
than giving oxaliplatin together with capecitabine.
PURPOSE: This randomized phase II trial is studying how well giving oxaliplatin together
with S-1 works compared to oxaliplatin given together with capecitabine in treating patients
with recurrent, metastatic, or unresectable gastric cancer.
OBJECTIVES:
Primary
- To evaluate the time to progression in patients with recurrent or metastatic gastric
cancer treated with oxaliplatin in combination with S-1 vs capecitabine.
Secondary
- 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
unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months for 6 months.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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