UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059825 |
|---|---|
| Receipt number | R000068413 |
| Scientific Title | A single-center prospective observational study on the efficacy of stereotactic body radiotherapy for painful spinal bone metastases |
| Date of disclosure of the study information | 2025/11/19 |
| Last modified on | 2025/11/19 13:44:05 |
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Basic information
Public title
A single-center prospective observational study on the efficacy of stereotactic body radiotherapy for painful spinal bone metastases
Acronym
SpineSBRT
Scientific Title
A single-center prospective observational study on the efficacy of stereotactic body radiotherapy for painful spinal bone metastases
Scientific Title:Acronym
SpineSBRT
Region
| Japan |
Condition
Condition
Painful spinal bone metastases from malignant tumors
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pane response and treatment-related toxicity of stereotactic body radiotherapy for painful spinal metastatic lesions from malignant tumors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete pain response rate at 3 months
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 20 years or older at the time of informed consent
2) Patients with an identified primary tumor and a pathological diagnosis of malignancy
3) Patients with painful spinal bone metastases scheduled to undergo stereotactic body radiotherapy
4) Patients whose pain score for the target metastatic lesion is 2 or higher
Key exclusion criteria
Stereotactic body radiotherapy cannot be performed under the current national health insurance system
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Nakamura |
Organization
National Cancer Center Hospital East
Division name
Department of Radiation Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
0471331111
masanaka@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Makita |
Organization
National Cancer Center Hospital East
Division name
Department of Radiation Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
0471331111
Homepage URL
kemaki3@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital Institutional Review Board
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
Tel
0471331111
irst@ml.res.ncc.go.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
| 2025 | Year | 11 | Month | 19 | 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
| 2024 | Year | 01 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the pain response and treatment-related toxicity of stereotactic body radiotherapy for painful spine metastatic lesions from malignant tumors
Management information
Registered date
| 2025 | Year | 11 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068413
