UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017673 |
|---|---|
| Receipt number | R000020487 |
| Scientific Title | Observation study of intraoperative radiation therapy for early breast cancer |
| Date of disclosure of the study information | 2015/05/25 |
| Last modified on | 2021/11/28 11:00:19 |
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Basic information
Public title
Observation study of intraoperative radiation therapy for early breast cancer
Acronym
Observation study of intraoperative radiation therapy
Scientific Title
Observation study of intraoperative radiation therapy for early breast cancer
Scientific Title:Acronym
Observation study of intraoperative radiation therapy
Region
| Japan |
Condition
Condition
Early breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To observe the safety and efficacy of IORT at a single dose of 21 Gy in Japanese breast cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Ipsilateral breast cancer recurence rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Tumor size<=2.0cm
2) No lymph node metastasis
3) Age>=50
4) Obtained written informed consent
Key exclusion criteria
1) Sentinel lymph node metastasis
2) Surgical margin is clinically potive
3) Contraindicated for radiation therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Sawaki |
Organization
Aichi Cancer Center Hospital
Division name
Breast Oncology
Zip code
464
Address
1-1 Kanokoden - Chikusa-ku
TEL
052-762-6111
m-sawaki@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Sawaki |
Organization
Aichi Cancer Center Hospital
Division name
Breast Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya
TEL
052-762-6111
Homepage URL
m-sawaki@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board of Aichi Cancer Center in Hospital Management Bureau
Address
1-1 Kanokoden, Chikusa-ku, Nagoya
Tel
052-762-6111
irb@aichi-cc.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
愛知県がんセンター中央病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 25 | 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
| 2015 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Adverse Events are evaluated by the National Cancer Institute Common Terminology Criteria for Adverse
Events (NCI CTCAE), version 4.0. After surgery, each patient will be
scheduled for anually evaluations for 5 years with physical examinations and photographic records.
Management information
Registered date
| 2015 | Year | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020487
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
