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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Oxaliplatin

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