UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
Region	Japan

Condition
Condition	pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	the completion rate of TS-1 adjuvant chemotherapy
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	75

Research contact person
Name of lead principal investigator	Toyama Hirochika
Organization	Kobe University school of Medicine
Division name	Department of surgery
Address	7-5-2,Kusunokicyou,Cyuuouku, Kobe-shi Hyogo, Japan
TEL	078-382-6302
Email	toyama@med.kobe-u.ac.jp

Public contact
Name of contact person	Toyama Hirochika
Organization	Kobe University school of Medicine
Division name	Department of surgery
Address	7-5-2,Kusunokicyou,Cyuuouku, Kobe-shi Hyogo, Japan
TEL	078-382-6302
Homepage URL
Email	toyama@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University school of Medicine
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 09 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 11 Month 09 Day
Anticipated trial start date	2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 09 Day
Last modified on	2017 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034140