Trial of the effectiveness of nutritional intervention for patients who are administered TS-1 after surgical resection of pancreatic cancer
- Conditions
- pancreatic cancer
- Registration Number
- JPRN-jRCT1051180068
- Lead Sponsor
- Toyama Hirochika
- Brief Summary
The number of compatible cases was extremely small and could not be analyzed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 35
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)total bilirubin <= 1.5mg/dL
f)AST/ALT <= 100 IU/L
g)Creatinin clearance >= 40ml/min
CC by Cockcroft-Gault method is avilable
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the completion rate of S-1 adjuvant chemotherapy
- Secondary Outcome Measures
Name Time Method 1)Nutrition Indicator:Body weight,BMI,s-Albumin,s-Protein,s-Cholesterol <br>2)RP of TS-1 on 4 courses <br>3)the rate and grade of complication with nutritional intervantion <br>4)RP of Elental <br>5)muscular volume