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

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01090505
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
73
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.

Condition or Disease Intervention/Treatment Phase
  • Drug: Drug: S-1 and oxaliplatin
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced
Study Start Date :
Nov 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2012
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Drug:S-1:80mg/m2;oxaliplatin 130mg/m2

Drug: Neoadjuvant chemotherapy(S-1+Oxaliplatin) followed by D2 gastrectomy

Drug: Drug: S-1 and oxaliplatin
Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
Other Names:
  • S-1:Taiho
  • Oxaliplatin：sanofi-aventis

    		•
    No Intervention: surgery

    Procedure/Surgery: Gastrectomy with D2 dissection

    Drug: Drug: S-1 and oxaliplatin
    Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
    Other Names:
  • S-1:Taiho
  • Oxaliplatin：sanofi-aventis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [5 years]

    Secondary Outcome Measures

    1. response rate [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. DISEASE CHARACTERISTICS:

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

    1. Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy

    2. Age:20 to 75

    3. Performance status:ECOG 0-2

    4. Life expectancy:Not specified

    5. Hematopoietic:WBC 4,000-12,000/mm3；Granulocyte count ≥ 2,000/mm3；Platelet count ≥ 100,000/mm^3；Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L；Bilirubin ≤ 1.5 mg/dL

    6. Adequate organ function

    7. Able to swallow oral medication

    8. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 China PLA General Hospital Beijing Beijing China 100853

    Sponsors and Collaborators

    • Chinese PLA General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01090505
    Other Study ID Numbers:
    • GC-ChinaPLAGH-2010
    First Posted:
    Mar 22, 2010
    Last Update Posted:
    Mar 22, 2010
    Last Verified:
    Nov 1, 2009
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Oxaliplatin

    Study Results

    No Results Posted as of Mar 22, 2010