UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008675 |
|---|---|
| Receipt number | R000010195 |
| Scientific Title | Multi-center study to evaluate the efficacy and to standardize RFA for early breast cancer |
| Date of disclosure of the study information | 2012/08/19 |
| Last modified on | 2024/02/19 09:09:09 |
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Basic information
Public title
Multi-center study to evaluate the efficacy and to standardize RFA for early breast cancer
Acronym
Multi-center study of RFA for early breast cancer
Scientific Title
Multi-center study to evaluate the efficacy and to standardize RFA for early breast cancer
Scientific Title:Acronym
Multi-center study of RFA for early breast cancer
Region
| Japan |
Condition
Condition
Early breast cancer
Classification by specialty
| Breast surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of RFA for early breast cancer to standardize it as local therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
5 years ipsilateral breast cancer recurennce rate
Key secondary outcomes
OS, DFS, AE, Imcomplete abtaion rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Radiofrequency ablation therapy
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
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
Ductal carcinoma ( Invasive or non-invasive) diagnosed by core-needle biopsy
T<=1.5cm on MMG, ultrasonography and MRI
cN0
Key exclusion criteria
PH of other malignat disease within 5 years
pregnancy
severe complication on heart and brain
disorder of blood coagulation
multiple lesions
lesions with EIC
simulateneous bilateral breast cancer
prior systemic therapy or radiotherapy to breast
Target sample size
372
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Kinoshita |
Organization
National Cancer Center Hospital
Division name
Division of Breast Surgery
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
takinosh@ncc.go.jp
Public contact
Name of contact person
| 1st name | Sota |
| Middle name | |
| Last name | Asaga |
Organization
National Cancer Center Hospital
Division name
Division of Breast Surgery
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
soasaga@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Supported by Grant-in-aid from MHLW
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center
Address
5-1-1,Tsukiji Chuo-ku Tokyo, Japan
Tel
0335422511
takinosh@ncc.go.jp
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
北海道がんセンター、群馬県立がんセンター、千葉県がんセンター、国立がん研究センター東病院、国立がん研究センター中央病院、大阪医療センター、四国がんセンター、岡山大学病院、広島市立広島市民病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010195
