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

This study is currently recruiting participants.
Verified November 2009 by Chinese PLA General Hospital
Sponsor:
Information provided by:
Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01090505
First received: March 16, 2010
Last updated: March 19, 2010
Last verified: November 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • response rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: L Chen, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01090505     History of Changes
Other Study ID Numbers: GC-ChinaPLAGH-2010
Study First Received: March 16, 2010
Last Updated: March 19, 2010
Health Authority: China: Ethics Committee

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013