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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007609
Receipt No. R000008985
Scientific Title A clinical trial of the effect of the elemental diet (Elental) on adverse events of DCF therapy (Docetaxel plus 5-fluorouracil and cisplatin) in patients with esophageal cancer.
Date of disclosure of the study information 2012/03/30
Last modified on 2018/10/03

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Basic information
Public title A clinical trial of the effect of the elemental diet (Elental) on adverse events of DCF therapy (Docetaxel plus 5-fluorouracil and cisplatin) in patients with esophageal cancer.
Acronym A clinical trial of the effect of the elemental diet on adverse events of DCF therapy in patients with esophageal cancer.
Scientific Title A clinical trial of the effect of the elemental diet (Elental) on adverse events of DCF therapy (Docetaxel plus 5-fluorouracil and cisplatin) in patients with esophageal cancer.
Scientific Title:Acronym A clinical trial of the effect of the elemental diet on adverse events of DCF therapy in patients with esophageal cancer.
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of supportive care by the elemental diet (Elental) against gastrointestinal toxicity from DCF therapy in patients with esophageal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes The incidence of gastrointestinal toxicity (grade 2 or higher) during three courses of DCF therapy
Key secondary outcomes The following are assesed during three courses of DCF therapy,
1) Incidence of adverse events
2) Nutritional condition s(body weght, muscle mass, blood test, urine analysis, N-balance)
3) Quality of Life
4) Response rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients of this trial group will take two packs of the elemental diet (Elental) a day as long as possible after initiation of DCF therapy.
When taking two packs is difficult, the dosage of the elemental diets (Elental) will be reduced suitable for the patient condition..
Interventions/Control_2 Patients of this control group will take regular diet only.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria The following patients
(1) patients with histological squamous cell carcinoma
(2) patients in stage II/III/IV (UICC ver.7)
(3) patients receiving DCF therapy (DTX750mg/m2,day1), CDDP(75mg/m2,day1), 5-FU(750mg/m2,day1-5)
(4) 20<=age of patient <=80years-old
(5) patients having PS=0,1,2
(6) patients being able to take the elemental diet (Elental)
(7) patients who agreed with written informed consent
Key exclusion criteria The following patients
(1) patients considered inadequate for inclusion in this trial by the physician
(2) patients with the past history of hypersensitivity to Elental
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wasaburo Koizumi
Organization Kitasato University School of Medicine
Division name Gastroenterology
Zip code
Address 1-15-1 Kitasato, Sagamihara, Kanagawa
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chikatoshi Katada
Organization Kitasato University School of Medicine
Division name Gastroenterology
Zip code
Address 1-15-1 Kitasato, Sagamihara, Kanagawa
TEL 042-778-8111
Homepage URL
Email ckatada@med.kitasato-u.ac.jp

Sponsor
Institute Department of Gastroenterology
Kitasato University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
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
2012 Year 03 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 No longer recruiting
Date of protocol fixation
2011 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2019 Year 02 Month 01 Day
Date analysis concluded
2019 Year 02 Month 10 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 29 Day
Last modified on
2018 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008985

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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