A randomized phase II study investigating an optimal dosing regimen of TS-1 plus CDDP plus Trastuzumab combination therapy for HER2-positive unresectable and/or recurrent gastric cancer
- Conditions
- nresectable and/or recurrent gastric cancer
- Registration Number
- JPRN-UMIN000008254
- Lead Sponsor
- Juntendo University School of Medicine Department of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Not provided
1)Subjects with synchronous double cancer or metachronous double cancer with a disease-free interval of less than five years(In-situ cancer, gastric cancer, mucosal cancer, differentiated adenocarcinoma, and skin cancer judged to be cured by treatment are not considered to be active double cancers.) 2)Subjects with a previous history of serious drug hypersensitivity 3)Subjects requiring continuous use of flucytosine, phenytoin, and/or warfarin potassium 4)Subjects being treated with pyrimidine fluoride antineoplastic agents other than TS-1(including any combination therapy) 5)Subjects with infectious diseases associated with a fever of 38.0 degrees C or higher 6)Subjects shown to be HBs antigen positive 7)Subjects with serious complications (interstitial pneumonia or pulmonary fibrosis, difficult-to-control diabetes, renal failure, hepatic failure, cardiac failure, bone-marrow suppression, and so on) 8)Subjects with diarrhea (more than four times daily or watery stool) 9)Subjects with accumulation of pleural and ascitic fluids requiring paracentesis for symptom relief 10)Subjects with the following cardiac diseases or conditions Previous history of congestive cardiac failure Angina pectoris requiring drug treatment Obvious transmural myocardial infarction on electrocardiograph Clinically-evident cardiac valvular disease Poorly-controlled hypertension (systolic BP>180mmHg and/or diastolic BP>100mmHg) High-risk uncontrolled arrhythmias A previous history of myocardial infarction Ischemic cardiac disease requiring treatment 11)Women of child-bearing potential (intention), pregnant or lactating women 12)Men desiring to have children 13)Subjects with a previous history of serious psychiatric diseases or being treated for such diseases and judged to be ineligible for participating in the study 14)Subjects judged by the investigator(s) to be inappropriate study participants for any other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method