UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042491 |
|---|---|
| Receipt number | 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 | 2026/05/24 11:58:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
h.harada@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
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
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
none
Publication of results
Published
Result
URL related to results and publications
DOI: 10.1093/jrr/rrae060
Number of participants that the trial has enrolled
232
Results
Pain relief was achieved in 52% at 2 months.
The cumulative incidence of SREs was 6.5% at 6 months.
The 6-month overall survival rate was 70.2%.
Results date posted
| 2026 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Median age 70
Participant flow
Eligible patients were enrolled consecutively until 10 cases had been reached at each site.
Adverse events
Grade 3 lymphopenia occurred in five patients (2%), ileus, pharyngeal mucositis and dysphagia each occurred in one patient (0.4%) each.
Outcome measures
Pain relief
Skeletal-related events
Six-month overall survival rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 09 | Day |
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 270 cases (upper limit per facility is 10 cases)
Registration; Dec 2020 to Mar 2021
Follow up; Until Sep 2021
Management information
Registered date
| 2020 | Year | 11 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048504
