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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033132
Receipt No. R000037785
Scientific Title Phase II trial of stereotactic body radiotherapy for non-spine bone metastases.
Date of disclosure of the study information 2018/06/25
Last modified on 2019/06/26

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Basic information
Public title Phase II trial of stereotactic body radiotherapy for non-spine bone metastases.
Acronym SBRT for non-spine bone mets.
Scientific Title Phase II trial of stereotactic body radiotherapy for non-spine bone metastases.
Scientific Title:Acronym SBRT for non-spine bone mets.
Region
Japan

Condition
Condition non-spine bone metastases
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate prospectively the palliative efficacy of SBRT for painful non-spine bone metastases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain-progression free rate at 6 months
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 SBRT of 35 Gy in 5 fractions for painful non-spine bone metastases
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 Male and Female
Key inclusion criteria 1. pathological or clinical diagnosis of non-spine bone metastases
2. painful non-spine metastases with NRPS of 2 or more
3. An hour resting in supine is possible
4. Age; 20-
5. Expected prognosis; 6 months or more
6. Written informed consent
Key exclusion criteria 1. The lesion is skull base bone
2. The lesion is radiosensitive tumor
3. Radiation history in the same area with 3 months
4. Serious medical or psychological problems
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyuki Karasawa
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Radiation Oncology
Zip code
Address 3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL 03-3823-2101
Email karasawa@cick.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Ito
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Radiation Oncology
Zip code
Address 3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL 03-3823-2101
Homepage URL http://www.cick.jp/houshasenchiryou/
Email keiito@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 06 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 Completed
Date of protocol fixation
2018 Year 05 Month 15 Day
Date of IRB
2018 Year 06 Month 25 Day
Anticipated trial start date
2018 Year 06 Month 25 Day
Last follow-up date
2019 Year 12 Month 20 Day
Date of closure to data entry
2020 Year 01 Month 15 Day
Date trial data considered complete
2020 Year 01 Month 15 Day
Date analysis concluded
2020 Year 01 Month 20 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 25 Day
Last modified on
2019 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037785

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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