pancreatic cancer
Conditions
Interventions
Treatment Scedule A total of 300kcal/day of Elental is administered for 42 days as one course. Two courses administration is required with Elental, another two course is permitted without Elental.
Sponsors
Kobe University school of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligebility Criteria during hospital state 1)patients 20 years old or more 2)proven pancreatic cancer histlogecally 3)confirmed by R0 or R1 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 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 during 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 |
|---|---|
| the completion rate of TS-1 adjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Nutrition Indicator:Body weight,BMI,s-Albumin,s-Protein,s-Cholesterol 2)RP of TS-1 on 4 courses 3)the rate and grade of complication with nutritional intervantion 4)RP of Elental 5)muscular volume | — |
Countries
Japan
Contacts
Public ContactToyama Hirochika
Kobe University school of Medicine Department of surgery
Outcome results
None listed