UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051399 |
|---|---|
| Receipt number | R000058073 |
| Scientific Title | A prospective interventional study to evaluate the efficacy and safety of radical resection and postoperative proton beam therapy for resectable borderline or unresectable locally advanced pancreatic cancer |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/06/21 11:48:01 |
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Basic information
Public title
Evaluation of efficacy and safety of postoperative proton beam therapy for resectable pancreatic cancer
Acronym
Postoperative proton therapy for resectable pancreatic cancer
Scientific Title
A prospective interventional study to evaluate the efficacy and safety of radical resection and postoperative proton beam therapy for resectable borderline or unresectable locally advanced pancreatic cancer
Scientific Title:Acronym
Evaluation of efficacy and safety of postoperative proton beam therapy for resectable pancreatic cancer
Region
| Japan |
Condition
Condition
Borderline resectable or unresectable locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To conduct a prospective interventional study to evaluate the efficacy of postoperative proton beam therapy after resection of borderline or unresectable locally advanced pancreatic cancer after tumor control with induction chemotherapy and radical resection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
efficacy and safety
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Proton therapy after radical surgery
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. borderline or unresectable pancreatic cancer
2. pathologically diagnosed
3. patient's informed consent
Key exclusion criteria
1. history of radiation therapy to the abdomen
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Terashima |
Organization
Hyogo Ion Beam Medical Center
Division name
Department of Radiology
Zip code
679-5165
Address
1-2-1, Koto, Shingucho, Tatsuno, Hyogo
TEL
0791-58-0100
terashima@kmyr.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Terashima |
Organization
Hyogo Ion Beam Medical Center
Division name
Department of Radiology
Zip code
679-5165
Address
1-2-1, Koto, Shingucho, Tatsuno, Hyogo
TEL
0791-58-0100
Homepage URL
terashima@kmyr.jp
Sponsor or person
Institute
Hyogo Ion Beam Medical Center
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics review committee, Hyogo Ion Beam Medical Center
Address
1-2-1, Koto, Shingucho, Tatsuno, Hyogo
Tel
0791-58-0100
yu.takasu@hibmc.shingu.hyogo.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
| 2023 | Year | 07 | Month | 01 | 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
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 21 | Day |
Last modified on
| 2023 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058073
