UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048444 |
|---|---|
| Receipt number | R000055210 |
| Scientific Title | Prospective observational study of Carbon ion radiotherapy for solitary fibrous tumor |
| Date of disclosure of the study information | 2022/07/25 |
| Last modified on | 2024/01/24 12:46:12 |
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Basic information
Public title
Prospective observational study of Carbon ion radiotherapy for solitary fibrous tumor
Acronym
Prospective observational study of Carbon ion radiotherapy for solitary fibrous tumor
Scientific Title
Prospective observational study of Carbon ion radiotherapy for solitary fibrous tumor
Scientific Title:Acronym
Prospective observational study of Carbon ion radiotherapy for solitary fibrous tumor
Region
| Japan |
Condition
Condition
solitary fibrous tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness of carbon ion radiotherapy for solitary fibrous tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
local control rate and overall survival rate
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
| 10 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient has a confirmed histological diagnosis of a solitary fibrous tumor.
The tumor is unresectable.
Performance status (ECOG) is 0 to 2.
Expected to survive more than 12 months.
Written consent for participation in this study will be obtained from the candidate.
Carbon ion radiotherapy will be performed in accordance with the protocol of the Japanese Society for Radiation Oncology.
Key exclusion criteria
Diagnosed with malignant solitary fibrous tumor.
The patient has a severe complication that is intolerable to treatment.
Concurrent systemic therapy (chemotherapy, molecular-targeted therapy, or immunotherapy) is administered during irradiation.
Active and refractory infection at the irradiated site.
Clinical, psychological, or other factors that the physician in charge considers inappropriate.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Imai |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
263-0024
Address
4-9-1 Anagawa Inage Chiba
TEL
0432063306
imai.reiko@qst.go.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Imai |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
263-0024
Address
4-9-1 Anagawa Inage Chiba
TEL
0432063306
Homepage URL
imai.reiko@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
4-9-1, Anagawa, Inage, Chiba
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology
Address
4-9-1 Anagawa Inage Chiba
Tel
0432063306
imai.reiko@qst.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
| 2022 | Year | 07 | Month | 25 | 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
| 2022 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multi-institutional observational study with a questionnaire survey.
Management information
Registered date
| 2022 | Year | 07 | Month | 24 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055210
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
