Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer
Not Applicable
- Conditions
- Stage III gastric cancer
- Registration Number
- JPRN-UMIN000004734
- Lead Sponsor
- School of Medicine, Keio University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
1) with serious complications (intestinal paralysis, ileus, interstitial pneumonia or pulmonary fibrosis, heart failure, kidney failure, liver failure etc) with history of severe drug allergy 2) with clinically important infection 3) with diarrhea 4) with gastrointestinal bleeding need to repeat blood transfusion 5) with hepatocirrhosis or icterus 6) with clinically important mental disorder need to treat 7) with clinically important heart disease need to treat (ischemic heart disease, cardiac dysrhythmia etc) 8) with uncontrollable diabetes mellitus 9) pregnant or nursing women or women who like be pregnant and willing to get pregnant 10) doctor's decision not to be registered to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method estimate the maximum tolerated dose(MTD) and recommended dose (RD) of adjuvant chemotherapy of S-1 with CDDP
- Secondary Outcome Measures
Name Time Method Adverse events