Phase I/II trial of neoadjuvant S-1/CDDP with concurrent radiation for locally Advanced gastric cancer
Phase 1
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000008941
- 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
- 52
Inclusion Criteria
Not provided
Exclusion Criteria
1) known sever drug allergies 2) with clinically important infection 3) with diarrhea 4) with intestinal paralysis or ileus 5) with interstitial pneumonia or pulmonary fibrosis 6) has history of radiation to chest or ilium 7) has active carcinoma 8) with uncontrollable diabetes mellitus 9) has complication which is clinically probrem 10) with clinically important mental disorder need to treat 11) pregnant or nursing women or women who like be pregnant and willing to get pregnant 12) administered flucytosine 13) being blood transfusion or need to blood transfusion 14) 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 Phase I estimate the maximum tolerated dose (MTD)and recommended dose (RD) of adjuvant chemotherapy of S-1 with CDDP Phase II Pathological response rate
- Secondary Outcome Measures
Name Time Method