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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005081
Receipt No. R000006043
Scientific Title the phase II study of chemotherapy with Docetaxel+Nedaplatin+5-FU(DNF) to esophageal cancer
Date of disclosure of the study information 2011/02/14
Last modified on 2015/02/14

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Basic information
Public title the phase II study of chemotherapy with Docetaxel+Nedaplatin+5-FU(DNF) to esophageal cancer
Acronym the phase II study of DNF therapy to esophageal cancer
Scientific Title the phase II study of chemotherapy with Docetaxel+Nedaplatin+5-FU(DNF) to esophageal cancer
Scientific Title:Acronym the phase II study of DNF therapy to esophageal cancer
Region
Japan

Condition
Condition StageII,III,IV non-resective esophageal cancer and recurrece ofesophageal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes efficacy
Key secondary outcomes overall survival time, safety, efficacy, progression free survival time

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 2010/12-2012/12
nedaplatin 70mg/m2 day1
Doc 60mg/m2 day1
5FU 700mg/m2/day day1-5
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.It is diagnosed as an esophageal carcinoma for histopathology or cytology.
2.It is advanced unresectable esophageal cancer (StageII, III or IV) or esophageal carcinoma recurrent.
3.the interval between last treatment(radiation, chemotherapy) and this study is 4 weeks or more.
4.There is evaluable lesion for treatment.
5.ECOG Performance status is 0-2.
6.We satisfy all the following conditions.
that examination of an equal day two weeks of registration day ago permits it
(1)4,000 white blood corpuscle >= /mm3 and 12,000 <= /mm3
(2)2,000 mature granulocyte >= /mm3
(3)100,000 blood platelet >= /mm3
(4)Haemoglobin >= 9.5g/dL
(5)1.5 fold upper limit in the hospital AST <= IU/L
(6)1.5 fold upper limit in the hospital ALT <= IU/L
(7)Bilirubin total <= 1.5mg/dL
(8)1.5 fold upper limit in the hospital Al-P <= IU/L
(9)Creatinine <= 1.2mg/dL
(10)PaO2 >= 60 torr (room air)
7.expected prognosis is 3 months or more.
8.About final examination participation, an agreement by a document from the person himself is obtained.
Key exclusion criteria 1.It is the patient having an anaphylactic history for DOC, CDGP, 5-FU and polysorbate "80" component pharmaceutical.
2.Severe complicate disease (malignant hypertension, severe heart failure, liver failure, liver cirrhosis, diabetes mellitus under inadequate control, bleeding disorders)
3.Infectious disease with fever up
4.Regardless of presence of a cause, it is motor paralysis, the patient having peripheral neuropathy, severe edema
5.pleural effusion or cardiac effusion need to treatment.
6.The patient having active multiple primary cancer.
7.During the pregnancy or a pregnant female patient we are possible or are nursing.
8.The patient having the interstitial pneumonia that is apparent by chest X-rays or CT or pulmonary fibrosis
9.The patient whom we merge psychosis or neurologic manifestation, and it is judged to have difficulty with participation to an examination.
10.the case that resarch contact doctor regards as inadequate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Miyazaki
Organization Gunma University Graduate School
Division name Department of General Surgical Science
Zip code
Address 3-39-22 Showa-machi, Maebashi-shi, Gunma
TEL 027-220-8224
Email tatsuyamiyazaki@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Miyazaki
Organization Gunma University Graduate School
Division name Department of General Surgical Science
Zip code
Address 3-39-22 Showa-machi, Maebashi-shi, Gunma
TEL 027-220-8224
Homepage URL
Email tatsuyamiyazaki@gunma-u.ac.jp

Sponsor
Institute Gunma University Graduate School Department of General Surgical Science
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 群馬大学医学部付属病院(群馬県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2014 Year 10 Month 01 Day
Date of closure to data entry
2014 Year 10 Month 01 Day
Date trial data considered complete
2014 Year 10 Month 01 Day
Date analysis concluded
2014 Year 10 Month 15 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 14 Day
Last modified on
2015 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006043

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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