Oxaliplatin and S-1 or Oxaliplatin and Capecitabine in Treating Patients With Recurrent, Metastatic, or Unresectable Gastric Cancer
Recruitment status was: Recruiting
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.
Drug: tegafur-gimeracil-oteracil potassium
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|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|
- Progression-free survival [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
Experimental: Arm I
Patients receive oral S-1 twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1.
Given IVDrug: tegafur-gimeracil-oteracil potassium
Experimental: Arm II
Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin as in arm I.
Given orallyDrug: oxaliplatin
- 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 unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months for 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985556
|Korea, Republic of|
|Yonsei Cancer Center at Yonsei University Medical Center|
|Seoul, Korea, Republic of, 120-752|
|Principal Investigator:||Hyun C. Chung, MD, PhD||Yonsei University|