UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036982 |
|---|---|
| Receipt number | R000041988 |
| Scientific Title | A retrospective multicenter study of carbon ion radiotherapy for bone and soft tissue sarcomas |
| Date of disclosure of the study information | 2019/06/10 |
| Last modified on | 2019/06/06 13:59:25 |
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Basic information
Public title
A retrospective multicenter study of carbon ion radiotherapy for bone and soft tissue sarcomas
Acronym
A retrospective multicenter study of carbon ion radiotherapy for bone and soft tissue sarcomas
Scientific Title
A retrospective multicenter study of carbon ion radiotherapy for bone and soft tissue sarcomas
Scientific Title:Acronym
A retrospective multicenter study of carbon ion radiotherapy for bone and soft tissue sarcomas
Region
| Japan |
Condition
Condition
bone and soft tissue sarcoma
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Retrospective analysis of safety and efficacy of carbon ion radiotherapy for bone and soft tissue sarcomas implemented in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival rate
Key secondary outcomes
local control rate, adverse event rate
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
The candidates are patients who underwent carbon ion radiotherapy for bone and soft tissue sarcomas in Japan between November 2003 and December 2014 meeting following conditions.
1) histological diagnosis is sarcomas
2) unresectable cases.
3) carbon ion radiotherapy with curative intent
4) measurable tumors
5) PS is 0-2 or/and KI is more than 60.
Key exclusion criteria
patients having systemic metastases
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Kamada |
Organization
National Institute of Radiological Sciences
Division name
Charged Particle Therapy Center
Zip code
263-0024
Address
4-9-1, Anagawa, Inage, Chiba
TEL
0432063306
kamada.tadashi@qst.go.jp
Public contact
Name of contact person
| 1st name | Certified Review Board |
| Middle name | |
| Last name | National Institutes for Quantum and Radiological Science and Technology |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
Certified Review Board
Zip code
263-0024
Address
4-9-1, Anagawa, Inage, Chiba
TEL
0432063306
Homepage URL
helsinki@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gunma University Heavy Ion Medical Center
Hyogo Ion Beam Medical Center
SAGA HIMAT
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum and Radiological Science and Technology Certified Review Board
Address
4-9-1, Anagawa, Inage, Chiba
Tel
0432063306
helsinki@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
| 2019 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
750
Results
unpublished
Results date posted
| 2019 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
unpublished
Participant flow
unpublished
Adverse events
unpublished
Outcome measures
unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2019 | Year | 06 | Month | 06 | Day |
Last modified on
| 2019 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041988
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
