UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048271 |
|---|---|
| Receipt number | R000055009 |
| Scientific Title | The retrospective analysis of the effectiveness and functional outcome of carbon ion radiotherapy for sarcoma in elder patients |
| Date of disclosure of the study information | 2022/07/06 |
| Last modified on | 2025/01/11 18:49:31 |
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Basic information
Public title
The retrospective analysis of the effectiveness and functional outcome of carbon ion radiotherapy for sarcoma in elder patients
Acronym
The retrospective analysis of the effectiveness and functional outcome of carbon ion radiotherapy for sarcoma in elder patients
Scientific Title
The retrospective analysis of the effectiveness and functional outcome of carbon ion radiotherapy for sarcoma in elder patients
Scientific Title:Acronym
The retrospective analysis of the effectiveness and functional outcome of carbon ion radiotherapy for sarcoma in elder patients
Region
| Japan |
Condition
Condition
sarcoma
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety by retrospective analysis of oncologic outcomes and using a questionnaire of limb function in elder patients with sarcoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
limb function and QOL
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients aged 70 years or older at the start of caron ion radiotherapy for sarcomas between April 2000 and March 2021 are analyzed. The questionnaire is performed for patients who do not have recurrence or metastases.
Key exclusion criteria
Patients or legal representatives refuse to use clinical data for this research or consent to conduct a questionnaire.
Target sample size
200
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
2630024
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
2630024
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
Japan
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 | 06 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2022 | Year | 07 | Month | 04 | Day |
Last modified on
| 2025 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055009
