UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000918 |
|---|---|
| Receipt number | 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 09:12:43 |
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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
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
sawapi@qc4.so-net.ne.jp
Sponsor or person
Institute
Nagoya University school of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001072
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
