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eoadjuvant docetaxel, oxaliplatin and S-1 therapy for large type 3 or type 4 gastric cancer

Phase 2
Conditions
Gastric cancer
Registration Number
JPRN-jRCTs051190060
Lead Sponsor
GOTO Masahiro
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
46
Inclusion Criteria

1) Histological proven adenocarcinoma
2) Borrmann type 4 or large (8cm or more by Enhanced abdominal CT or gastrointestinal endoscopy) type 3
3) No peritoneal metastasis (CY0 or CY1, and P0) by laparoscopy and CT within 28days.No sign of distant metastasis including liver metastasis or paraaortic lymph node metastasis
4) Length of esophageal invasion less or equal to 3cm by image examination within 28 days
5) Age between 20 and 80 at registration
6) Performance Status(ECOG):0,1
7) No prior treatment of chemotherapy or radiation therapy
8) Adequate organ function
9) Fair oral intake with or without bypass surgery
10) HER2 negative or not examined
11) Written informed consent from patient

Exclusion Criteria

1) Synchronous or metachronous (within 5 years) malignancies
2) Infectious disease requiring systemic treatment(over 38 degrees Celsius)
3) During pregnancy, postparturition, or during lactation
4) Severe mental disease
5) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration
6) Receiving continuous systemic corticosteroid or immunosuppressant treatment
7) Under treatment with flucytosine, phenytoin, or warfarin
8) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy
9) HBs antigen positive
10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT
11) Poorly controlled hypertension or diabetes
12) Patients judged inappropriate for the study by thephysicians

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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