UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018366 |
|---|---|
| Receipt number | R000021240 |
| Scientific Title | Prospective cohort study of neoadjuvant chemoradiotherapy using GEM and nabPTX for borderline resectable pancreatic cancer |
| Date of disclosure of the study information | 2015/07/23 |
| Last modified on | 2020/08/12 17:46:17 |
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Basic information
Public title
Prospective cohort study of neoadjuvant chemoradiotherapy using GEM and nabPTX for borderline resectable pancreatic cancer
Acronym
Prospective cohort study of neoadjuvant chemoradiotherapy using GEM and nabPTX for borderline resectable pancreatic cancer
Scientific Title
Prospective cohort study of neoadjuvant chemoradiotherapy using GEM and nabPTX for borderline resectable pancreatic cancer
Scientific Title:Acronym
Prospective cohort study of neoadjuvant chemoradiotherapy using GEM and nabPTX for borderline resectable pancreatic cancer
Region
| Japan |
Condition
Condition
Borderline resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the resectability and the efficacy of neoadjuvant chemoradiotherapy using GEM and nabPTX which attempt curative resection for borderline resectable pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Response rate
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
| Medicine |
Interventions/Control_1
Neoadjuvant chemotherapy using GEM and nabPTX
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Cases diagnosed BRPC
2.Cases which chemotherapy and radiation were not performed
3.Over twenty years of age
4.Cases whose performance status at ECOG is from 0 to 1
5.Good organ function
Neutrophil more than 1500, Platelet more than 100000, Hb more than 9, AST/ALT less than 7.5, T-Bil less than 2.0, Cr less than 1.5
Key exclusion criteria
1.Medical history of severe drug allergy
2.Cases which have severe complication
3.A pregnant woman, a woman who is probably pregnant, and a man who expect patner's pregnancy
4.Cases which have active infection with a fever over 38 degrees
5.Peripheral neuropathy more than grade 2
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryutaro Mori |
Organization
Yokohama city university graduate school of medicine
Division name
Department of gastroenterological surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004 Japan
TEL
045-787-2650
ryutaromori@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Miyake |
Organization
Yokohama city university graduate school of medicine
Division name
Department of gastroenterological surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004 Japan
TEL
045-787-2650
Homepage URL
miyekentarou@yahoo.co.jp
Sponsor or person
Institute
Department of gastroenterological surgery, Yokohama city university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of gastroenterological surgery, Yokohama city university graduate school of medicine
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
| 2015 | Year | 07 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
duration of therapy: one year
follow-up period: three years
Management information
Registered date
| 2015 | Year | 07 | Month | 21 | Day |
Last modified on
| 2020 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021240
| 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 |
