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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014462
Receipt No. R000016828
Scientific Title Phase I/II study of docetaxel/CDGP/5-FU for advanced or recurrent esophageal cancer
Date of disclosure of the study information 2014/07/02
Last modified on 2017/07/04

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Basic information
Public title Phase I/II study of docetaxel/CDGP/5-FU for advanced or recurrent esophageal cancer
Acronym Phase I/II study of DNF for advanced or recurrent esophageal cancer
Scientific Title Phase I/II study of docetaxel/CDGP/5-FU for advanced or recurrent esophageal cancer
Scientific Title:Acronym Phase I/II study of DNF for advanced or recurrent esophageal cancer
Region
Japan

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

Objectives
Narrative objectives1 To determine the recommended dose (RD) of DNF therapy and efficacy in the treatment of esophageal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Phase I
To determine the recommended dose (RD)
Phase II
Safety, Tumor responses
Key secondary outcomes

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 Chemotherapy of docetaxel, nedaplatin and 5-fluorouracil
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 (1) histologically proven esophageal cancer
(2) clinical stage IV b (UICC-TMN) or recurrenced case
(3) age 20; 80 years
(4) an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
(5) adequate baseline bone marrow function, adequate hepatic function
adequate renal function, adequate respiratory and cardiac function.
(6) a life expectancy of at least 3 months.

(7) Written informed consent was obtained from all patients.
Key exclusion criteria
(1) history of drug hypersensitivity.
(2) active concomitant malignancy.
(3) serious complications (severe heart disease, active infection)
(4) pregnant or lactating females.
(5) The investigator considers not suitable for the study.
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Sato
Organization Tokushima University Graduate School of Biomedical Sciences
Division name Department of Community Medicine for Gastroenterology and Oncology
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima city
TEL +81-88-633-7122
Email takayama@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Sato
Organization Tokushima University Graduate School of Biomedical Sciences
Division name Department of Community Medicine for Gastroenterology and Oncology
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima city
TEL +81-88-633-7122
Homepage URL
Email sato.yasushi@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization Tokushima University
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 02 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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 02 Day
Last modified on
2017 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016828

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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