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Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Drug: S-1 and oxaliplatin
Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Both
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
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
Location
China PLA General Hospital
Beijing, Beijing, China
Status: Recruiting
Contact: Fu xing road 28# - 86-10-66938328
Start Date
November 2009
Completion Date
December 2015
Sponsors
Chinese PLA General Hospital
Source
Chinese PLA General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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