The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer

Launched by CHINESE ACADEMY OF MEDICAL SCIENCES · Feb 10, 2012

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ClinConnect Summary

There was no evidence of standard chemotherapy for advanced gastric cancer (AGC) in China. Fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of AGC. Capecitabine/cisplatin combination therapy showed an overall response rate (ORR) of 41- 55%, a median time to progression/progression free survival (TTP/PFS) of 5.6-6.3 months, and a median overall survival (OS) of 10.1-10.5 months. Though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both S-1 and capecitabine appear to be comparable in terms of efficacy an...

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Eligibility criteria

• Inclusion Criteria:
• • Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma
• • Measurable lesion and/or non-measurable lesion defined by RECIST
• • ECOG performance status ≦ 1
• • Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
• • Creatine ≦ upper normal limit (UNL)
• • Total bilirubin ≦ 1.5 X UNL
• • AST, ALT and ALP ≦ 2.5 x UNL
• • Subjects must be able to take orally
• • No prior chemotherapy
• • Life expectancy estimated than 3 months
• • Written informed consent
• Exclusion Criteria:
• • Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
• • Known brain metastases
• • History of hypersensitivity to fluoropyrimidines, oxaliplatin
• • Active double cancer
• • Treatment with any investigational product during the last 4 weeks prior to study entry
• • Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0
• • Any previous chemotherapy or radiotherapy for AGC