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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027839
Receipt No. 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 2019/06/24

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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

Not applicable
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
Email 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
Email myossy@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

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
Email 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 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031892

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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