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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041948
Receipt No. R000047314
Scientific Title Intensity-modulated stereotactic body radiotherapy with simultaneous integrated-boost in patients with bone metastasis of the spine
Date of disclosure of the study information 2020/10/01
Last modified on 2020/11/05

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Basic information
Public title Intensity-modulated stereotactic body radiotherapy with simultaneous integrated-boost in patients with bone metastasis of the spine
Acronym SIB-IM-SBRT for bone metastasis of the spine
Scientific Title Intensity-modulated stereotactic body radiotherapy with simultaneous integrated-boost in patients with bone metastasis of the spine
Scientific Title:Acronym SIB-IM-SBRT for bone metastasis of the spine
Region
Japan

Condition
Condition Bone metastasis of the spine
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy and safety regarding intensity-modulated stereotactic body radiotherapy with simultaneous integrated-boost in patients with bone metastasis of the spine.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 1-year local control rate
Key secondary outcomes Acute and late adverse events
Progression free survival
Overall survival

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 Maneuver
Interventions/Control_1 The patients with spinal bone metastases will receive SIB-IM-SBRT with 30 Gy in 5 fractions.
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.Patients with bone metastasis of the spine
2.Life expectancy of at least 1 year
3.Aged 20<= years
4.ECOG performance status 0-2
5.Written informed consent
Key exclusion criteria 1.Patients who had a previous RT to the treatment area
2.Dose constraints of organs at risk are not observed
3.Patients requiring radiotherapy for oncologic emergencies
4.Cases that the dose distribution can not be evaluated exactly.
5.Patients who have psychosis or psychiatric symptoms that interferes with daily life
6.Patients who are unsuitable for enrolment into the study by the investigator's judgment.
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Takamasa
Middle name
Last name Mitsuyoshi
Organization Kobe City Medical Center General Hospital
Division name Department of Radiation Oncology
Zip code 650-0047
Address 2-chome, Minami-cho, Minatojima, Chuo-ku, Kobe
TEL 078-302-4321
Email mitsu.t@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Takamasa
Middle name
Last name Mitsuyoshi
Organization Kobe City Medical Center General Hospital
Division name Department of Radiation Oncology
Zip code 650-0047
Address 2-chome, Minami-cho, Minatojima, Chuo-ku, Kobe
TEL 078-302-4321
Homepage URL
Email mitsu.t@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kobe City Medical Center General Hospital
Address 2-chome, Minami-cho, Minatojima, Chuo-ku, Kobe
Tel 078-302-4321
Email mitsu.t@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
2020 Year 10 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 Open public recruiting
Date of protocol fixation
2020 Year 09 Month 01 Day
Date of IRB
2020 Year 09 Month 26 Day
Anticipated trial start date
2020 Year 09 Month 26 Day
Last follow-up date
2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2025 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2020 Year 09 Month 30 Day
Last modified on
2020 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047314

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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