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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
Sponsor:
Information provided by:
Chinese PLA General Hospital

Study Description
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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
Gastric Cancer Drug: Drug: S-1 and oxaliplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Oxaliplatin
U.S. FDA Resources

Arms and Interventions
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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
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Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. response rate [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090505


Contacts
Contact: L Chen, MD 86-10-66938028 litbj301@sina.com

Locations
China, Beijing
China PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Fu xing road 28#    86-10-66938328      
Sponsors and Collaborators
Chinese PLA General Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: L Chen, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01090505     History of Changes
Other Study ID Numbers: GC-ChinaPLAGH-2010
First Posted: March 22, 2010    Key Record Dates
Last Update Posted: March 22, 2010
Last Verified: November 2009

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents