UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044984 |
|---|---|
| Receipt number | R000051070 |
| Scientific Title | A prospective observational study of palliative radiotherapy for painful tumor |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2025/01/28 11:03:57 |
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Basic information
Public title
A prospective observational study of palliative radiotherapy for painful tumor
Acronym
A prospective observational study of palliative radiotherapy for painful tumor
Scientific Title
A prospective observational study of palliative radiotherapy for painful tumor
Scientific Title:Acronym
A prospective observational study of palliative radiotherapy for painful tumor
Region
| Japan |
Condition
Condition
Metastatic cancers
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess pain response rate, duration of pain response, and re-irradiation rate after palliative radiotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete response rate after 3 months
Key secondary outcomes
1. pain response rate (CR+PR) after 1 month, 3 months, 6 months, 9 months, and 12 months
2. incidence of fracture and spinal cord compression after treatment
3. adverse events
4. survival time
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
Palliative radiotherapy for the painful tumor is planed.
Key exclusion criteria
1. radiotherapy for postoperative lesion
2. radiotherapy for intracranial lesion
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yutaro |
| Middle name | |
| Last name | Koide |
Organization
Aichi Cancer Center
Division name
Department of Radiation Oncology
Zip code
464-8681
Address
Kanokoden 1-1, Chikusa, Nagoya
TEL
0527626111
ykoide@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Yutaro |
| Middle name | |
| Last name | Koide |
Organization
Aichi Cancer Center
Division name
Department of Radiation Oncology
Zip code
464-8681
Address
Kanokoden 1-1, Chikusa, Nagoya
TEL
0527626111
Homepage URL
ykoide@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center, Department of Radiation Oncology
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
Aichi Cancer Center IRB
Address
Kanokoden 1-1, Chikusa, Nagoya
Tel
0527626111
irb@aichi-cc.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
| 2021 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Target number of registrations: 300
Registration: Aug 2021 to Jul 2023
Follow up: until 1 year from the last case registration date
Management information
Registered date
| 2021 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051070
