UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004732 |
|---|---|
| Receipt number | 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 15:10:37 |
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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
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
susomkia@medicine.psu.ac.th
Sponsor or person
Institute
Department of Surgery, Faculty of Medicine, Prince of Songkla University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005636
