Study of PSK combination therapy to the reduction of adverse events by TS-1 in advanced gastric cancer
Not Applicable
- Conditions
- Gastric cancer
- Registration Number
- JPRN-UMIN000013313
- Lead Sponsor
- Faculty of Medicine, Kagawa University Department of Gastroenterological Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1)Schronous, mtaschronous double cancer/ multiple cancer 2)administration contraindication of TS-1 (refer package insert) 3)Regular use of flucytosine, phenytoin or warfarin potassium 4)History of severe drug allergy (grade 3>=) 5)Severe complications such as paralytic ileus, bowel obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure and hepatic failure etc. 6)Severe watery diarrhea 7)Pregnancy or lactation 8)Male intension that get with child 9)HIV positive 10)Patients who are recognized as inadequate patients by doctors whit responsibility in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events rate after starting chemotherapy (number of adverse event cases /number of enrolled cases)
- Secondary Outcome Measures
Name Time Method TS-1 compliance (number of therapy completion courses/number of therapeutic plan courses) Quality of Life