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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004732
Receipt No. R000005636
Scientific Title Randomized trial of immuno-enhancing enteral nutrition in esophageal cancer patients undergoing chemoradiation
Date of disclosure of the study information 2010/12/30
Last modified on 2014/06/16

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Basic information
Public title Randomized trial of immuno-enhancing enteral nutrition in esophageal cancer patients undergoing chemoradiation
Acronym Immuno-enhancing enteral nutrition in esophageal cancer patients undergoing chemoradiation
Scientific Title Randomized trial of immuno-enhancing enteral nutrition in esophageal cancer patients undergoing chemoradiation
Scientific Title:Acronym Immuno-enhancing enteral nutrition in esophageal cancer patients undergoing chemoradiation
Region
Asia(except Japan)

Condition
Condition esophageal carcinoma
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 - reduce side effects of chemoradiation
- cytokine levels
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes reduce side effects of chemoradiation
Key secondary outcomes cytokine levels

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 immuno-enhancing enteral nutrition (Neomune)
Interventions/Control_2 enteral nutrition (Blendera)
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
75 years-old >=
Gender Male and Female
Key inclusion criteria -squamous cell esophageal carcinoma
-sign consent
Key exclusion criteria -ECOG2 or over
-with organ metastasis
-with other active cancer
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Somkiat Sunpaweravong, MD
Organization Prince of Songkla University Hospital, Songkla, 90110 Thailand
Division name Department of Surgery
Zip code
Address Prince of Songkla University Hospital, Songkla, 90110 Thailand
TEL 6674-429384
Email susomkia@medicine.psu.ac.th

Public contact
Name of contact person
1st name
Middle name
Last name Somkiat Sunpaweravong, MD
Organization Prince of Songkla University Hospital, Songkla, 90110 Thailand
Division name Department of Surgery
Zip code
Address Prince of Songkla University Hospital, Songkla, 90110 Thailand
TEL 6674-429384
Homepage URL
Email susomkia@medicine.psu.ac.th

Sponsor
Institute Department of Surgery, Faculty of Medicine, Prince of Songkla University
Institute
Department

Funding Source
Organization Prince of Songkla University Hospital
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Thailand

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 Prince of Songkla University Hospital, Songkla, 90110 Thailand

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 30 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 Enrolling by invitation
Date of protocol fixation
2010 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2012 Year 10 Month 01 Day
Date of closure to data entry
2012 Year 10 Month 01 Day
Date trial data considered complete
2012 Year 10 Month 01 Day
Date analysis concluded
2012 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 12 Month 15 Day
Last modified on
2014 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005636

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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