UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020705 |
|---|---|
| Receipt number | R000023893 |
| Scientific Title | Safety and efficacy evaluation of postoperative whole breast radiotherapy in prone position for Japanese Women |
| Date of disclosure of the study information | 2016/01/23 |
| Last modified on | 2019/07/31 14:02:09 |
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Basic information
Public title
Safety and efficacy evaluation of postoperative whole breast radiotherapy in prone position for Japanese Women
Acronym
Safety and efficacy evaluation of postoperative whole breast radiotherapy in prone position for Japanese Women
Scientific Title
Safety and efficacy evaluation of postoperative whole breast radiotherapy in prone position for Japanese Women
Scientific Title:Acronym
Safety and efficacy evaluation of postoperative whole breast radiotherapy in prone position for Japanese Women
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This prospective study aimed to analyze the safety and efficacy of whole breast radiotherapy treated in the prone position.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the frequency and severity of acute radiation toxicities
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Postoperative whole breast radiotherapy was delivered in the prone position.
Interventions/Control_2
Postoperative whole breast radiotherapy was delivered in the supine position.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with stage 0-II breast cancer(invasive or non-invasive).
Large or pendulous breasts (Japanese bra size C or larger, or the widest measurements of the bust equal to or over 95 cm).
Undergoing partial mastectomy in National Cancer Center Hospital.
Three or less axillary lymph node metastasis.
Written informed consents were obtainted.
Key exclusion criteria
History of irradiation to the ipsilateral breast.
Concurrent malignancy.
Bilateral breast cancer.
Active connective tissue disorders.
In pregnancy.
Severe infection.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Kagami |
Organization
School of Medicine,Showa University
Division name
Department of Radiation Oncology
Zip code
142-0064
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
TEL
03-3784-8000
kagami@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Takahashi |
Organization
National Cancer Center Hospital
Division name
Department of Radiation Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL
03-3542-2511
Homepage URL
kantakah@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, National Cancer Cener
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
Tel
03-3542-2511
NCC_IRBoffice@ml.res.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5041564/
Number of participants that the trial has enrolled
22
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
| 2009 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2009 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2009 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 22 | Day |
Last modified on
| 2019 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023893
