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

This study is currently recruiting participants.
Verified November 2013 by Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Lin Yang, Chinese Academy of Medical Sciences Identifier:
First received: February 6, 2012
Last updated: November 26, 2013
Last verified: November 2013

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

Condition Intervention Phase
Stomach Neoplasms
Drug: Oxaliplatin
Drug: s1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer

Resource links provided by NLM:

Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    From date of treatment was administered until the date of first documented response to treatment according to RECIST criteria,assessed every 2 cycles

  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    From date of treatment was administered until the date of death from any cause,assessed every 3 months

  • number of participants with adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    assessed from treatment was administered until 1 months after withdrawing from study

Estimated Enrollment: 44
Study Start Date: June 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
Drug: Oxaliplatin
130mg/m2 d1,repeated q21d
Other Name: eloxatin
Drug: s1
80mg/m2/d, d1-14,repeated q21d
Other Name: TS-1

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01531452

Contact: Wen Zhang, MD 86-10-87788145
Contact: Lin Yang, MD 86-10-87788145

China, Beijing
cancer hospital & Institute,Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Wen Zhang, MD    86-10-87788145      
Contact: Lin Yang, MD    86-10-87788145   
Principal Investigator: Lin Yang, MD         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Principal Investigator: Jinwan Wang, MD cancer hospital&institute,Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Lin Yang, MD, Chinese Academy of Medical Sciences Identifier: NCT01531452     History of Changes
Other Study ID Numbers: CH-GI-016
Study First Received: February 6, 2012
Last Updated: November 26, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
Stomach Neoplasms
drug therapy

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014