Gastric Cancer
Conditions
Interventions
Tolerance Test of Elental 1)Patients take Ellental during 14 days after the start of oral intake. 2)A 100Kcal of Elental is administered three times between each meal (total 300Kcal/day) = test dose
Sponsors
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligebility Criteria during hospital stat 1)patients 20 years old or more 2)proven gastric cancer histlogecally 3)Stage II or Stage III confirmed by R0 surgery 4)PS (ECOG) between 0 and 2 5)wityout any prior chemotherapy and/or radiation therapy 6)with good oral intake 7)written informed consent to participate in this study 8)without any postoperative complications Eligebility criteria after discharge (second registration) Patients registerd in hospital are rechecked for the second registration 1)Stage II (except patients T1 or T3/N0) or Stage III diagnosed at the surgical operation and/or intra-peritoneal cytological examination 2)Patients who can take 60% or more of the test dose of Elental 3)without any severe diseases and with a good condition of important organs for administration of TS-1 a)WBC >= 2,500/mm3 b)neutrophil >= 1,200/mm3 c)platelet >=75,000/mm3 d)hemoglobin >= 8.0g/L e)AST/ALT <= 100 IU/L f)total bilirubin <= 1.5mg/dL g)Creatinin clearance >= 40ml/min CC by Cockcroft-Gault method is avilable
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 70% of Relative Performance (RP) of TS-1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroshi Furukawa
Kinki University School of Medicine Department of surgery
Outcome results
None listed