UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042286 |
|---|---|
| Receipt number | R000048277 |
| Scientific Title | Long-term outcome of carbon ion radiotherapy for elderly pancreatic cancer patients |
| Date of disclosure of the study information | 2020/10/30 |
| Last modified on | 2021/10/31 14:46:38 |
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Basic information
Public title
Long-term outcome of carbon ion radiotherapy for elderly pancreatic cancer patients
Acronym
Carbon ion radiotherapy for elderly pancreatic cancer patients
Scientific Title
Long-term outcome of carbon ion radiotherapy for elderly pancreatic cancer patients
Scientific Title:Acronym
Carbon ion radiotherapy for elderly pancreatic cancer patients
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of carbon ion radiotherapy for elderly pancreatic cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year overall survival
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly patients aged 80 years or more treated with carbon ion radiotherapy between November 2017 to December 2018.
Key exclusion criteria
None
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Shinoto |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
QST Hospital
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba,
TEL
0432063306
shinoto.makoto@qst.go.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Shinoto |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
QST Hospital
Zip code
2638555
Address
4-9-1 Anagawa, Inage-ku, Chiba,
TEL
0432063306
Homepage URL
shinoto.makoto@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Self fundign
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum and Radiological Science and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba,
Tel
0432064706
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
| 2020 | Year | 10 | Month | 30 | 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
46
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
retrospective observative study
Management information
Registered date
| 2020 | Year | 10 | Month | 29 | Day |
Last modified on
| 2021 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048277
| 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 |
