A phase II trial of tri-week cycle TS-1+L-OHP+Trastuzumab combination therapy for HER2 positive advanced or recurrent gastric cancer
- Conditions
- gastric cancer
- Registration Number
- JPRN-UMIN000021209
- Lead Sponsor
- Dokkyo Medical University Saitama Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Not provided
1) Who cannot administrate TS-1, L-OHP and Trastuzumab 2)Pregnant and / or nursing women or men who wish to have children in future 3)With active infectious disease 4)Positive for HBs antigen 5)Have a history or current symptoms of heart failure, uncontrollable arrhythmia, angina pectoris, valvular disease and uncontrollable hypertension 6)With interstitial pneumonia, pulmonary fibrosis, heart failure, renal failure, hepatic failure and uncontrollable diabetes mellitus 7)With dyspnea at rest 8)With active bleeding from gastric cancer or ulcer 9)With severe diarrhea (over 4 times a day or watery diarrhea) 10)With active double cancers excluding carcinoma in situ and / or prior curative cancer with relapse free for more than 5 years 11)Under medication of flucytosine or phenytoin,or warfarin 13)Under continuous medication of steroids 14)Judged to be unfit for this study by investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method incidence and extent of adverse events, progression-free survival, overall survival, time to treatment failure