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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032291
Receipt No. R000036822
Scientific Title Phase II trial to evaluate compliance of postoperative nutrition by Uplead in total gastrectomy for gastric cancer
Date of disclosure of the study information 2018/04/17
Last modified on 2018/04/17

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Basic information
Public title Phase II trial to evaluate compliance of postoperative nutrition by Uplead in total gastrectomy for gastric cancer
Acronym Uplead trial
Scientific Title Phase II trial to evaluate compliance of postoperative nutrition by Uplead in total gastrectomy for gastric cancer
Scientific Title:Acronym Uplead trial
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the feasibility of postoperative Uplead after total gastrectomy for gastric cancer case.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes compliance with supplementation
Key secondary outcomes body weight and lean body mass reduction 1 month and 3 months after surgery

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
Food
Interventions/Control_1 Supplementation of Uplead
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 i. Histologically proven adenocarcinoma of the stomach
ii.Clinical T1-T4a and no distant metastasis
iii.R0 resection is possible by open total gastrectomy
iv.Enough oral intake after sugery
v.Age ranging between 20 and more.
vi.ECOG performance status 0-1.
vii.Not cancer of the remnant stomach
viii.Suficient organ functions.
iv.Written informed consent.
Key exclusion criteria i.Synchronous or metachronous cancer (synchronous multiple cancers in the stomach included).
ii.Active inflammation which requires systemic treatment
iii.Allergy for contents of Uplead
iv.Uncontrollable diabetes mellitus
v.Systemic treatment with corticosteroid
vi.Unstable angina or cardiac infarction within 6 months
vii.Pulmonary disorder under oxygen
viii.Woman with on-going pregnancy or breast-feeding, or contemplating pregnancy.
ix.Mental disorders which may affect ability or willingness to provide informed consent or abide by the study protocol
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaki Yoshikawa
Organization Kanagawa Cancer Center
Division name Department of Gastrointestinal Surgery
Zip code
Address 2-3-2 Nakao Asahi Yokohama Kanagawa Japan
TEL +81-45-520-2222
Email yoshikawat@kcch.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takanobu Yamada
Organization Kanagawa Cancer Center
Division name Department of Gastrointestinal Surgery
Zip code
Address 2-3-2 Nakao Asahi Yokohama Kanagawa Japan
TEL +81-45-520-2222
Homepage URL
Email tknbymd@kcch.jp

Sponsor
Institute Kanagawa Cancer Center
Institute
Department

Funding Source
Organization non-profit organization KSATTS
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 04 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 17 Day
Last modified on
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036822

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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