UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009118 |
|---|---|
| Receipt number | R000004292 |
| Scientific Title | A randomised trial comparing gemcitabine vs TS-1 in patients with resected pancreatic cancer. |
| Date of disclosure of the study information | 2012/10/15 |
| Last modified on | 2014/04/15 09:44:55 |
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Basic information
Public title
A randomised trial comparing gemcitabine vs TS-1 in patients with resected pancreatic cancer.
Acronym
A randomised trial comparing gemcitabine vs TS-1
Scientific Title
A randomised trial comparing gemcitabine vs TS-1 in patients with resected pancreatic cancer.
Scientific Title:Acronym
A randomised trial comparing gemcitabine vs TS-1
Region
| Japan | Asia(except Japan) |
Condition
Condition
resected pancreas cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
A randomised phase comparing gemcitabine vs TS-1 in patients with resected pancreatic cancer:Adjuvant Therapy for Pancreatic Cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
time to recurrence
Key secondary outcomes
over all survival
safty
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
GEM
Interventions/Control_2
TS-1
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
| 65 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients never had malignacy before pancreas cancer.
Key exclusion criteria
age
allegy
Patietns aggremant
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi kubota |
Organization
Dokkyo Medical University
Division name
Second Department of Surgery
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-87-2158
shimodamitsugi@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsugi Shimoda |
Organization
Dokkyo Medical University
Division name
Second Department of Surgery
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0283-87-2158
Homepage URL
shimodamitsugi@hotmail.com
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
| 2012 | Year | 10 | Month | 15 | 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
Completed
Date of protocol fixation
| 2008 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 15 | Day |
Last modified on
| 2014 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004292
| 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 |
