UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045898 |
|---|---|
| Receipt number | R000052397 |
| Scientific Title | Effectiveness of radical stereotactic body radiotherapy for vertebral bone metastasis |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2021/10/28 14:01:11 |
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Basic information
Public title
Effectiveness of radical stereotactic body radiotherapy for vertebral bone metastasis
Acronym
SBRT for vertebral bone metastasis
Scientific Title
Effectiveness of radical stereotactic body radiotherapy for vertebral bone metastasis
Scientific Title:Acronym
SBRT for vertebral bone metastasis
Region
| Japan |
Condition
Condition
The patients with vertebral bone metastasis
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effectiveness of radiation therapy for spinal metastases. Local control time and overall survival.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local control time and overall survival.
Key secondary outcomes
EORTC Grade 3 or higher appearance frequency
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
| Maneuver |
Interventions/Control_1
Effectiveness when irradiating 30 Gy using SBRT
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who do not meet the exclusion criteria
Key exclusion criteria
Primary lesion is not controlled
Metastases to other sites
Life prognosis within 1 month
I can't communicate
Radiation therapy cannot be planned depending on the site of cancer
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Tanaka |
Organization
Asahi University Hospital
Division name
Radiation Oncology
Zip code
5008523
Address
3-23 Hashimoto-cho, Gifu city, Gifu
TEL
0582538001
c.bluered@gmail.com
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Tanaka |
Organization
Asahi University Hospital
Division name
Radiation Oncology
Zip code
5008523
Address
3-23 Hashimoto-cho, Gifu city, Gifu
TEL
0583747635
Homepage URL
c.bluered@gmail.com
Sponsor or person
Institute
Asahi University
Institute
Department
Personal name
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
Asahi University Hospital
Address
3-23 Hashimoto-cho, Gifu city, Gifu
Tel
0582538001
c.bluered@gmail.com
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
| 2021 | Year | 10 | Month | 29 | 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
| 2021 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 28 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052397
