Unique ID issued by UMIN | UMIN000029895 |
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Receipt number | R000034140 |
Scientific Title | A prospective study to verify the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection of pancreatic cancer |
Date of disclosure of the study information | 2017/11/09 |
Last modified on | 2017/11/09 13:17:11 |
A prospective study to verify the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection of pancreatic cancer
A prospective study to verify the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection of pancreatic cancer
A prospective study to verify the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection of pancreatic cancer
A prospective study to verify the effectiveness of a element supplement "Elental" for patients who are administered TS-1 after surgical resection of pancreatic cancer
Japan |
pancreatic cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
It is intended to verify whether the completion rate of TS-1 adjuvant chemotherapy is increased by the nutritional intervation by Elental after pancreatic surgical resection.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
the completion rate of TS-1 adjuvant chemotherapy
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
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.
One course(with Elental) :
TS-1 continuous administration for 28 days,after 14 days rest.
Elental continuous administration for 42 days.
One course(without Elental) :
TS-1 continuous administration for 28 days,after 14 days rest.
20 | years-old | <= |
Not applicable |
Male and Female
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 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
75
1st name | |
Middle name | |
Last name | Toyama Hirochika |
Kobe University school of Medicine
Department of surgery
7-5-2,Kusunokicyou,Cyuuouku, Kobe-shi Hyogo, Japan
078-382-6302
toyama@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Toyama Hirochika |
Kobe University school of Medicine
Department of surgery
7-5-2,Kusunokicyou,Cyuuouku, Kobe-shi Hyogo, Japan
078-382-6302
toyama@med.kobe-u.ac.jp
Kobe University school of Medicine
self funding
Self funding
NO
2017 | Year | 11 | Month | 09 | Day |
Unpublished
Preinitiation
2017 | Year | 11 | Month | 09 | Day |
2018 | Year | 01 | Month | 01 | Day |
2017 | Year | 11 | Month | 09 | Day |
2017 | Year | 11 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034140
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