UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041189 |
|---|---|
| Receipt number | R000047031 |
| Scientific Title | Exploration of novel preoperative treatments for pancreatic cancer based on the resectability classification |
| Date of disclosure of the study information | 2020/07/22 |
| Last modified on | 2020/07/22 10:39:53 |
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Basic information
Public title
Exploration of novel preoperative treatments for pancreatic cancer based on the resectability classification
Acronym
Novel preoperative treatments for pancreatic cancer
Scientific Title
Exploration of novel preoperative treatments for pancreatic cancer based on the resectability classification
Scientific Title:Acronym
Novel preoperative treatments for pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the significance of preoperative treatments for pancreatic cancer stratified by the resectability classification.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resection rate, R0 resection rate
Key secondary outcomes
Overall survival rate, Recurrence-free survival rate, Safety and efficacy of preoperative treatments
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pancreatic adenocarcinoma
Tolerable for surgery
Maintaining normal bone marrow, liver, and renal functions
Maintaining oral intake
Written informed consent
Key exclusion criteria
Refusal of participation
Interstitial pneumonia
Other types of pancreatic cancer
Intolerable for surgery
Presence of treatments prior to the enrollment
Double cancer
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Kubota |
Organization
Dokkyo Medical University
Division name
Second Department of Surgery
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Tochigi
TEL
0282872158
kubotak@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Aoki |
Organization
Dokkyo Medical University
Division name
Second Department of Surgery
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Tochigi
TEL
0282872158
Homepage URL
aoki-2su@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu, Tochi 3210293 Japan
Tel
0282861111
aoki-2su@dokkyomed.ac.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 | 07 | Month | 22 | 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
| 2019 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Resectable cancer: NAC(Gemcitabine +S-1)
BR-PV cancer: NAC(Gemcitabine +Nab-PTX)
BR-A cancer: NACRT
UR-LA cancer: chemoradiation/conversion surgery
Management information
Registered date
| 2020 | Year | 07 | Month | 22 | Day |
Last modified on
| 2020 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047031
| 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 |
