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Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01090505
Recruitment Status : Unknown
Verified November 2009 by Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : March 22, 2010
Last Update Posted : March 22, 2010
Information provided by:

March 16, 2010
March 22, 2010
March 22, 2010
November 2009
December 2012   (Final data collection date for primary outcome measure)
overall survival [ Time Frame: 5 years ]
Same as current
No Changes Posted
response rate [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced
The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Cancer
Drug: Drug: S-1 and oxaliplatin
Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
Other Names:
  • S-1:Taiho
  • Oxaliplatin:sanofi-aventis
  • Experimental: Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
    Drug: Neoadjuvant chemotherapy(S-1+Oxaliplatin) followed by D2 gastrectomy
    Intervention: Drug: Drug: S-1 and oxaliplatin
  • No Intervention: surgery
    Procedure/Surgery: Gastrectomy with D2 dissection
    Intervention: Drug: Drug: S-1 and oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2015
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:


    Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)

  2. Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
  3. Age:20 to 75
  4. Performance status:ECOG 0-2
  5. Life expectancy:Not specified
  6. Hematopoietic:WBC 4,000-12,000/mm^3;Granulocyte count ≥ 2,000/mm^3;Platelet count ≥ 100,000/mm^3;Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L;Bilirubin ≤ 1.5 mg/dL
  7. Adequate organ function
  8. Able to swallow oral medication
  9. Written informed consent

Exclusion Criteria:

  1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
  2. Pregnant or breast-feeding women
  3. Severe mental disease
  4. Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
  5. Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
  6. Myocardial infarction within six disease-free months
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
L Chen, Chinese PLA General Hospital
Chinese PLA General Hospital
Not Provided
Not Provided
Chinese PLA General Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP