A phase II study to confirm the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection (OGSG 1108)
- Conditions
- Gastric Cancer
- Registration Number
- JPRN-UMIN000006872
- Lead Sponsor
- Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
- Brief Summary
Primary endpoint: S-1 completion rate In the PPS, the S-1 completion rate was 69.0% (95% CI: 56.9-79.5). When stratified by surgical method, S-1 completion rates were 68.0% (95% CI: 46.5-85.1) for TG and 69.6% (95% CI: 54.2-82.2) for DG.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 82
Not provided
Exclusion Criteria duriong hospital stay 1)with active double cancer (*) *Simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years. Carcinoma in situ or cancers localized in membranous layer are not included to double cancer. Cancers removed by EMR/ESD are included. 2)with a history of allergy against TS-1 and/or Elental 3)with active infection diseases 4)with uncontrollable hypertension 5)with uncontrollable DM 6)with severe heart diseases clinically 7)with severe lung diseases (interstitial pneumonitis,pulmonary fibrosis, or pulmonary emphysema) 8)with psychologic diseases and/or psychological symptpms 9)women pregnant and/or nursing or women who like to be pregnant 10)patient registered to the other study whose endpoints are same to This study. 11)patients whom doctor decide not to register to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 70% of Relative Performance (RP) of TS-1
- Secondary Outcome Measures
Name Time Method 1)Nutrition Indicator : Body Weight, BMI, s-Albumin, s-Protein, s-Cholesterol 2)PR of TS-1 on 8 courses 3)AE of TS-1 4)PR of Elental 5)Ratio of patients who were tolerant to the test dose of Elental