NCT01531452

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

a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 and safety. The investigators conducted a phase II trial of oxaliplatin combined with S-1 in the treatment of first-line AGC.

Conditions

• Stomach Neoplasms

Interventions

Type	Name	Description
DRUG	Oxaliplatin	130mg/m2 d1,repeated q21d
DRUG	s1	80mg/m2/d, d1-14,repeated q21d

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-11-01
• Completion: 2013-06-01
• First posted: 2012-02-13
• Last updated: 2014-12-04

Locations

1 site across 1 country: China