UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020834 |
|---|---|
| Receipt number | R000023652 |
| Scientific Title | A study evaluating the safety of dose-dense EC with pegfilgrastim. |
| Date of disclosure of the study information | 2016/02/02 |
| Last modified on | 2018/09/23 11:43:17 |
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Basic information
Public title
A study evaluating the safety of dose-dense EC with pegfilgrastim.
Acronym
A study evaluating the safety of dose-dense EC with pegfilgrastim.
Scientific Title
A study evaluating the safety of dose-dense EC with pegfilgrastim.
Scientific Title:Acronym
A study evaluating the safety of dose-dense EC with pegfilgrastim.
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of ddEC with pegfilgrastim.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
rate of severe adverse event
Key secondary outcomes
rate of febrile neutropenia, oher adverse event
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
ddEC therapy;
epirubicine 90mg/m2 Day1
cyclophosphamide 600mg/m2 Day1
PEG-filgrastim 3.6mg Day4
q14, 4 cycle
evaluate at 3 months afer the last registration.
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1 Patients requiring ddEC therapy
2 informed consent
3 EF>50
4 20<=age<70
5 ECOG PS: 0-1
Key exclusion criteria
1 allergic for G-CSF
2 a case of active infection
3 pregnancy or breast-feeding
4 severe comobidity
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Kubo |
Organization
Fukuyama city hospital
Division name
Department of Breast and thyroid surgery
Zip code
Address
5-23-1 Zao-cho, Fukuyama city , Hiroshisma
TEL
084-941-5151
shikubo@city.fukuyama.hiroshima.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Kubo |
Organization
Fukuyama city hospital
Division name
Department of Breast and thyroid surgery
Zip code
Address
5-23-1 Zao-cho, Fukuyama city , Hiroshisma
TEL
084-941-5151
Homepage URL
shikubo@city.fukuyama.hiroshima.jp
Sponsor or person
Institute
Fukuyama city hospital
Institute
Department
Personal name
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
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
| 2016 | Year | 02 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 13 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 13 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 13 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 01 | Day |
Last modified on
| 2018 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023652
