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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000918
Receipt No. R000001072
Scientific Title Phase I/II study of Intraoperative radiation therapy in early breast cancer
Date of disclosure of the study information 2008/10/01
Last modified on 2015/06/01

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Basic information
Public title Phase I/II study of Intraoperative radiation therapy in early breast cancer
Acronym Phase I/II study of Intraoperative radiation therapy in early breast cancer
Scientific Title Phase I/II study of Intraoperative radiation therapy in early breast cancer
Scientific Title:Acronym Phase I/II study of Intraoperative radiation therapy in early breast cancer
Region
Japan

Condition
Condition early breast cancer
Classification by specialty
Breast surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To study safety and efficacy of intraoperative radiation therapy for early breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes short safety (within 3 months after operation)
Key secondary outcomes efficacy, long safety

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
Maneuver
Interventions/Control_1 Intraoperative radiotherapy for breast conservative operation
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
50 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1) T>2.5cm
2) hope for breast conservative operation
3) age older than 50 years
4) marjin is more than 1cm
5) diagnosed marjin is free pathologically intraoperation
6) patologically lymph node negative
7) informed consent is signed
Key exclusion criteria 1) contraindications to radiation therapy
2) past given the radiation therapy for breast or chest
3) have extensive intraductal component
4) have a tumor located in the axillary tail of the breast
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuneo Imai
Organization Nagoya University school of Medicine
Division name Breast and Endocrine Surgery
Zip code
Address 65 tsurumai-cho showa-ku Nagoya city
TEL 052-744-2251
Email m-sawaki@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Sawaki
Organization Aichi Cancer Center Hospital
Division name Breast Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya
TEL 052-762-6111
Homepage URL
Email sawapi@qc4.so-net.ne.jp

Sponsor
Institute Nagoya University school of Medicine
Institute
Department

Funding Source
Organization None
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
2008 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2007 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2015 Year 04 Month 28 Day
Date of closure to data entry
2015 Year 04 Month 28 Day
Date trial data considered complete
2015 Year 04 Month 28 Day
Date analysis concluded
2015 Year 04 Month 28 Day

Other
Other related information

Management information
Registered date
2007 Year 12 Month 01 Day
Last modified on
2015 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001072

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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