a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer
18 Years
N/A
Both
Stomach Neoplasms
Trial Information
a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Description:
from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Jinwan Wang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
cancer hospital&institute,Chinese Academy of Medical Sciences
Authority:
China: Food and Drug Administration
Study ID:
CH-GI-016
NCT ID:
NCT01531452
Start Date:
June 2011
Completion Date:
December 2013
Related Keywords:
- Stomach Neoplasms
- Stomach Neoplasms
- drug therapy
- oxaliplatin
- s1
- Neoplasms
- Stomach Neoplasms
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