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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042491
Receipt No. R000048504
Scientific Title Multiinsitutional prospective observational study of Radiotherapy for metastatis bone tumor
Date of disclosure of the study information 2020/12/01
Last modified on 2020/11/18

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Basic information
Public title Multiinsitutional prospective observational study of Radiotherapy for metastatis bone tumor
Acronym Multiinsitutional prospective observational study of Radiotherapy for metastatis bone tumor
Scientific Title Multiinsitutional prospective observational study of Radiotherapy for metastatis bone tumor
Scientific Title:Acronym Multiinsitutional prospective observational study of Radiotherapy for metastatis bone tumor
Region
Japan

Condition
Condition Metastatic bone tumor
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the actual patients characteristics and therapeutic effect of radiation therapy for bone metastasis in clinical practice in Japan
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)type of cancer, treatment policy, irradiation method
Key secondary outcomes 2)pain response, skeletal related event
3)Toxicity
4)Quality of life,employment status

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Radiotherapy for bone metastasis is planned
Written informed consent
Key exclusion criteria Inappropriate for study participation by the treating physician
Target sample size 280

Research contact person
Name of lead principal investigator
1st name Hideyuki
Middle name
Last name Harada
Organization Shizuoka Cancer Center
Division name Radiation and Proton Therapy Center
Zip code 4118777
Address 1007 shimonagakubo, Nagaizumi, Shizuoka
TEL 0559895222
Email h.harada@scchr.jp

Public contact
Name of contact person
1st name Hideyuki
Middle name
Last name Harada
Organization Shizuoka Cancer Center
Division name Radiation and Proton Therapy Center
Zip code 4118777
Address 1007 shimonagakubo, Nagaizumi, Shizuoka
TEL 0559895222
Homepage URL
Email h.harada@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
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 Shizuoka Cancer Center IRB
Address 1007 shimonagakubo, Nagaizumi, Shizuoka
Tel 0559895222
Email tansaku_office@scchr.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
2020 Year 12 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
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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 09 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Target number of registrations: Maximum 280 cases (upper limit per facility is 10 cases)
Registration; Dec 2020 to Mar 2021
Folloe up; Until Sep 2021

Management information
Registered date
2020 Year 11 Month 18 Day
Last modified on
2020 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048504

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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