UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003544 |
|---|---|
| Receipt number | R000004300 |
| Scientific Title | A randomised phase II trial comparing gemcitabine vs TS-1 in patients with resected pancreatic cancer |
| Date of disclosure of the study information | 2010/04/27 |
| Last modified on | 2013/10/27 10:50:09 |
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Basic information
Public title
A randomised phase II trial comparing gemcitabine vs TS-1 in patients with resected pancreatic cancer
Acronym
Adjuvant Therapy for resected Pancreatic Cancer:TS-1 vs Gemcitabine
Scientific Title
A randomised phase II trial comparing gemcitabine vs TS-1 in patients with resected pancreatic cancer
Scientific Title:Acronym
Adjuvant Therapy for resected Pancreatic Cancer:TS-1 vs Gemcitabine
Region
| Japan |
Condition
Condition
Curative resection for pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Efficacy and safty in patients with adjuvant chemotherapy for pancreatic cancer: TS-1 vs gemcitabine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
disease free survival
Key secondary outcomes
over all survival
side effect
QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
gemcitabine
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
age (65 yrs</= or 64 yrs >)
stage: I, II or III, IV
tumor location (head or body-tail)
Key exclusion criteria
In patietns with preoperative chemo, chemo radiation.
no good oral intake
less than 20 yrs old
PS 2 < (ECOG)
poor fanction for bone marrow, liver, kidney and lung etc.
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 | Tokihiko Sawada |
Organization
Dokkyo Medical University
Division name
Second Department of Surgery
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-87-2158
Homepage URL
tsawada@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
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
| 2010 | Year | 04 | Month | 27 | 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
Completed
Date of protocol fixation
| 2007 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 26 | Day |
Last modified on
| 2013 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004300
