a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer
Overview
- Phase
- Phase 2
- Intervention
- Oxaliplatin
- Conditions
- Stomach Neoplasms
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Progression Free Survival
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Lin Yang
MD
Chinese Academy of Medical Sciences
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
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
- •by NCI-CTCAE ver.3.0
- •Any previous chemotherapy or radiotherapy for AGC
Arms & Interventions
treatment
oxaliplatin+s1
Intervention: Oxaliplatin
treatment
oxaliplatin+s1
Intervention: s1
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: 2 years
from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks
Secondary Outcomes
- overall survival(2 years)
- number of participants with adverse events(2 years)
- Response Rate(2 years)