UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025675 |
|---|---|
| Receipt number | R000029539 |
| Scientific Title | Observational study of neoadjuvant GS chemotherapy for patients with pancreatic cancer |
| Date of disclosure of the study information | 2017/01/14 |
| Last modified on | 2020/07/22 09:53:37 |
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Basic information
Public title
Observational study of neoadjuvant GS chemotherapy for patients with pancreatic cancer
Acronym
Neoadjuvant GS chemotherapy for pancreatic cancer
Scientific Title
Observational study of neoadjuvant GS chemotherapy for patients with pancreatic cancer
Scientific Title:Acronym
Neoadjuvant GS chemotherapy 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
Assesment of safety and efficacy of neoadjuvant chemotherapy using gemcitabine and S1 for patients with oancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety and efficacy of the neoadjuvant GS chemotherapy
Key secondary outcomes
Changes in tumour size and tumour markers, resection rate and R0 resection 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
Two cycles of neoadjuvant chemotherapy using Gemcitabine(100mg/m2,day1,day8) and S1(100mg/body or 120mg/body, day1-day14)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)clinical diagnosis of pancreatic cancer
2)no distant metastasis
3)possible macroscopic curative resection
4)treatment naive
5)presence of measurable lesion
6)possible oral intake of S1
7)possible written informed consent
8)age not less than 20
Key exclusion criteria
1)patients with lung fibrosis and/or interstitial pneumoniae
2)unresectable SMA invasion
3)active double cancer
4)active infectious disease
5)creatinine clearance < 30mL/min
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Kubota |
Organization
Dokkyo Medical University Hospital
Division name
Second department of surgery
Zip code
3210293
Address
Kitakobayashi 880, Mibu, Tochigi, Japan
TEL
0282861111
kubotak@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Aoki |
Organization
Dokkyo Medical University Hospital
Division name
Second department of surgery
Zip code
3210293
Address
Kitakobayashi 880, Mibu, Tochigi, Japan
TEL
0282861111
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
+81-282-86-1111
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
| 2017 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 14 | 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=R000029539
| 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 |
