UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027839 |
|---|---|
| Receipt number | R000031892 |
| Scientific Title | Development and applicability of a new elastic immobilization with metal marker for postoperative radiotherapy for breast cancer |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2019/12/23 10:10:25 |
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Basic information
Public title
Development and applicability of a new elastic immobilization with metal marker for postoperative radiotherapy for breast cancer
Acronym
Breast markerless radiotherapy
Scientific Title
Development and applicability of a new elastic immobilization with metal marker for postoperative radiotherapy for breast cancer
Scientific Title:Acronym
Breast markerless radiotherapy
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the dosimetric changes, reproducibility of the elastic immobilization with metal markers, and assess the safety.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
rate of acute toxicity
Key secondary outcomes
evaluation of accuracy of a new elastic immobilization with metal marker and availability of
the immobilization
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
| Device,equipment |
Interventions/Control_1
obtain CT images and perform radiotherapy wearing elastic immobilization with metal markers
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
| 100 | years-old | > |
Gender
Female
Key inclusion criteria
Stage 0,1,2
DCIS, invasive ductal carcinoma
>=20 years old
partial breast resection
no radiotherapy for SC and IMN
no previous radiotherapy
informed consent
PS0-1
oriental woman understood in Japanese
Key exclusion criteria
active double cancer
active infection
fever
mental disorder
DM(HbA1c>=7.0)
collagen disease
systematic steroid therapy
cardiovascular disease
IP,serious COPD
pregnancy
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mizowaki |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Radiation Oncology and Image-applied Therapy
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
075-366-7654
mizo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Yoshimura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Radiation Oncology and Image-applied Therapy
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
075-366-7654
Homepage URL
myossy@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Society
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
Department of Ethics Support, Kyoto University Hospital
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
| 2017 | Year | 07 | Month | 01 | 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
15
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
| 2017 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 20 | Day |
Last modified on
| 2019 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031892
| Research Plan | |
|---|---|
| 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 |
