UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014462 |
|---|---|
| Receipt number | 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 09:37:05 |
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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
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
sato.yasushi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016828
