UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010860 |
|---|---|
| Receipt number | 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 13:29:22 |
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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
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
yoshihirotana11@hotmail.com
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012712
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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