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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Chinese PLA General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090505
First Posted: March 22, 2010
Last Update Posted: March 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chinese PLA General Hospital
  Purpose
The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.

Condition Intervention Phase
Gastric Cancer Drug: Drug: S-1 and oxaliplatin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • overall survival [ Time Frame: 5 years ]

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

Estimated Enrollment: 160
Study Start Date: November 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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

Responsible Party: L Chen, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01090505     History of Changes
Other Study ID Numbers: GC-ChinaPLAGH-2010
First Submitted: March 16, 2010
First Posted: March 22, 2010
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