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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010860
Receipt No. R000012712
Scientific Title Effect of Elemental diet with docetaxel , cisplatin and fluorouracil (DCF) in Preoperative Oesophagus Cancer patients
Date of disclosure of the study information 2013/06/04
Last modified on 2018/04/05

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Basic information
Public title Effect of Elemental diet with docetaxel , cisplatin and fluorouracil (DCF) in Preoperative Oesophagus Cancer patients
Acronym EPOC study
Scientific Title Effect of Elemental diet with docetaxel , cisplatin and fluorouracil (DCF) in Preoperative Oesophagus Cancer patients
Scientific Title:Acronym EPOC study
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Surgery in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Reserch for incidence of oral mucositis that occur in DCF therapy for esophageal cancer patients, safety of elemental diet Elental administration.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes oral mucositis (over grade2)
Key secondary outcomes Toxicity except for oral mucositis, safety of Elental, response rate of chemotherapy, resection rate, completion rate of chemotherapy, weight, QOL survey (QLQ-C30)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Primary tumor is either neck, chest, abdomen esophagus. You have been diagnosed with either squamous cell carcinoma, adenocarcinoma squamous cell carcinoma, adenocarcinoma of histopathologically.
It is esophageal cancer StageII registration and III, it can be a surgery by chemotherapy or adaptation of surgery. Age of the registration date is 75 years old 20 years of age or older. ECOG Performance Status is 0 or 1. There is no history of radiation therapy chemotherapy, chemical and radiation therapy for all cancer types, including esophageal cancer. Organ function is maintained. There is no brain metastases with symptoms. Is not allowed pleural effusion of moderate or more, the ascites. Can be taken of enteral nutrition and oral intake enough. For the study participants, written consent from the person is obtained.
Key exclusion criteria It is complicated by diabetes treatment by the continued use of insulin. Or mucous membranes (carcinoma in situ) carcinoma in situ, which is determined to be treated by topical treatment but patients that with a double cancer of activity is not included in the double cancer of active lesions in cancer equivalent. DOC, CDDP ,5-FU, and patients with a history of hypersensitivity to polysorbate 80-containing formulation. Patients with contraindications to administration Elental. I have a history of hypersensitivity to Elental. I have disorders of amino acid metabolism
I have a fungal infection and bacterial activity. patients receiving systemic administration's ongoing steroids. Regardless of the presence or absence of cause, motor paralysis, and has a peripheral neuropathy. Patients with or without cause, admit edema. Patients with pulmonary fibrosis or interstitial pneumonia evidenced by CT or chest X-ray. Patients is determined participation in the test is difficult and complicated by psychiatric symptoms or psychosis. Patients participating in the clinical trial of the other endpoint is a duplicate. Patients with a possibility of pregnancy or during pregnancy. Cases study director doctor has determined to be inappropriate as a target for this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Tanaka
Organization Gifu University
Division name Surgical Oncology
Zip code
Address 1-1 Yanagido Gifu city
TEL 058-230-6000
Email yoshihirotana11@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Tanaka
Organization Gifu university
Division name surgical oncology
Zip code
Address 1-1 Yanagido Gifu City
TEL 0582306000
Homepage URL
Email yoshihirotana11@hotmail.com

Sponsor
Institute Gifu University
Institute
Department

Funding Source
Organization EA pharmacotheuticus
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor ajinomoto pharmacotheuticus
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
2013 Year 06 Month 04 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 Completed
Date of protocol fixation
2012 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2015 Year 06 Month 30 Day

Other
Other related information Investigation for Phase2/3

Management information
Registered date
2013 Year 06 Month 03 Day
Last modified on
2018 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012712

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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