UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033796 |
|---|---|
| Receipt number | R000038543 |
| Scientific Title | Phase 2 study of S-IROX as down staging chemotherapy for borderline resectable pancreatic cancer |
| Date of disclosure of the study information | 2018/08/20 |
| Last modified on | 2018/08/17 19:34:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase 2 study of S-IROX as down staging chemotherapy for borderline resectable pancreatic cancer
Acronym
BR-SIROX
Scientific Title
Phase 2 study of S-IROX as down staging chemotherapy for borderline resectable pancreatic cancer
Scientific Title:Acronym
BR-SIROX
Region
| Japan |
Condition
Condition
pancreatic cancer(borderline resectable)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
effectiveness of sirox as down staging chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
R0 Resectability
Key secondary outcomes
RFS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
chemotherapy
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Borderline Resectable
Key exclusion criteria
History of treatment of other cancer
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Shimada |
Organization
National Canser Center
Division name
Department of Hepatobiliary and Pancreatic Surgery
Zip code
Address
5-1-1 Tsukiji Chuouku Tokyo
TEL
03-3542-2511
kshimada@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuta Maruki |
Organization
National Canser Center
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
Address
5-1-1 Tsukiji Chuouku Tokyo
TEL
03-3542-2511
Homepage URL
ymaruki@ncc.go.jp
Sponsor or person
Institute
Department of Hepatobiliary and Pancreatic Oncology/Surgery
National Canser Center
Institute
Department
Personal name
Funding Source
Organization
Self-sourcing
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
Address
Tel
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
| 2018 | Year | 08 | Month | 20 | 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
| 2018 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 25 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 25 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 25 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 17 | Day |
Last modified on
| 2018 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038543
