UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023435 |
|---|---|
| Receipt number | R000026489 |
| Scientific Title | A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes |
| Date of disclosure of the study information | 2016/08/30 |
| Last modified on | 2016/08/01 21:43:14 |
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Basic information
Public title
A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes
Acronym
A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes
Scientific Title
A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes
Scientific Title:Acronym
A confirmation study of omitting axillary dissection in patients with breast cancer and positive sentinel nodes
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety of omitting axillary dissection in patients with breast cancer and one to two postive sentinel nodes.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5year axillary recurrence rate
Key secondary outcomes
1)Overall survival
2)recurrence-free suvival
3)local recurrence-free suvival
4)the rate of upper-limb lymphedema
5)Quality of life
6)comparison of axillary recurrence rate between patients with two or more nodes dissected and only one positive node and those with other situation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
to omit axillary dissection for patients
with one to two positve sentinel lymph nodes
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
Female
Key inclusion criteria
1) diagnosed as breast cancer by core needle/vacuum assisted biopsy
2)clinical N0
3)planned to undergo lumpectomy and radiation therapy
4)written informed consent
Key exclusion criteria
prior therapy
T3,T4
M1
Target sample size
189
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Okamoto |
Organization
Tokyo Women's Medical University
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
Kawadacho 8-1, Shinjuku-ku, Tokyo
TEL
03-3353-8111
okamoto.takahiro@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Hirano |
Organization
Tokyo Women's Medical University, Medical Center East
Division name
Department of Breast Surgery
Zip code
Address
Nishi-ogu 2-1-10, Arakawa-ku, Tokyo
TEL
03-3810-1111
Homepage URL
ahirasu@dnh.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical 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
| 2016 | Year | 08 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | 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
| 2016 | Year | 08 | Month | 01 | Day |
Last modified on
| 2016 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026489
