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

Phase 2
18 Years
Open (Enrolling)
Stomach Neoplasms

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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

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

- Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0

- Any previous chemotherapy or radiotherapy for AGC

Type of Study:


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:


Principal Investigator

Jinwan Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

cancer hospital&institute,Chinese Academy of Medical Sciences


China: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

December 2013

Related Keywords:

  • Stomach Neoplasms
  • Stomach Neoplasms
  • drug therapy
  • oxaliplatin
  • s1
  • Neoplasms
  • Stomach Neoplasms