UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056380 |
|---|---|
| Receipt number | R000064257 |
| Scientific Title | Prognostic factors in carbon ion radiotherapy for pancreatic cancer |
| Date of disclosure of the study information | 2024/12/06 |
| Last modified on | 2024/12/04 11:05:46 |
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Basic information
Public title
Prognostic factors in carbon ion radiotherapy for pancreatic cancer
Acronym
Prognostic factors in carbon ion radiotherapy for pancreatic cancer
Scientific Title
Prognostic factors in carbon ion radiotherapy for pancreatic cancer
Scientific Title:Acronym
Prognostic factors in carbon ion radiotherapy for pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the factors that prolong the prognosis after carbon ion radiotherapy and the optimal treatment method by comparing the cases of pancreatic cancer treated with carbon ion radiotherapy and chemotherapy at QST Hospital and those treated only with chemotherapy at Chiba University Hospital from a retrospective viewpoint.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
local control rate, progression free survival, adverse event
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
Cases of locally advanced pancreatic cancer treated with carbon ion radiotherapy (including chemotherapy) at QST Hospital from April 2016 through March 2024.
Cases of locally advanced pancreatic cancer treated with chemotherapy at chiba university hospital from April 2016 through March 2024.
Key exclusion criteria
Cytology or histology from the primary pancreatic lesion has not been performed.
Has a history of radiotherapy other than those included in this study at the site to be treated.
Active overlapping cancer.
Has distant metastasis.
The subject or his/her representative refuses to allow the use of his/her clinical data for this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kurosaki |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
TEL
043-206-3306
kurosaki.hiroki@qst.go.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kurosaki |
Organization
National Institutes for Quantum and Radiological Science and Technology
Division name
QST Hospital
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
TEL
043-206-3306
Homepage URL
kurosaki.hiroki@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board, National Institutes for Quantum and Radiological Science and Technology
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
Tel
043-206-3306
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
| 2024 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064257
