UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004148 |
|---|---|
| Receipt number | R000004979 |
| Scientific Title | Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 for resectable pancreatic carcinoma |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2017/09/07 09:10:16 |
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Basic information
Public title
Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 for resectable pancreatic carcinoma
Acronym
Prep-01
Scientific Title
Phase II study of Neoadjuvant chemotherapy with Gemcitabine and S1 for resectable pancreatic carcinoma
Scientific Title:Acronym
Prep-01
Region
| Japan |
Condition
Condition
resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and feasibilty for gemcitabine and S1 therapy as Neoadjuvant therapy against pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2 year survival rate
Key secondary outcomes
Adverse effect, resectability rate, residual tumor(R), nodal involvement(N), pathological effect, recurrence free survival, tumor marker, dose intensity
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 treatment with gemcitabine and S1
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) invasive ductal carcinoma of the pancreas
2) no distant metastasis
3) R0/1 resectable
4) all adult who anticipate to undergo pancreatectomy
5) no prior therapy
6) written informed consent
Key exclusion criteria
1) pulmonary fibrosis or interstitial pneumonitis
2) tumor other than ductal carcinoma
3) distant metastasis
4) R2 resection
5) prior anti-cnacer therapy
6) pregnancy
7) under 20 years old
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Unno |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of gastroenterological surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
fmotoi@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuyuhiko Motoi |
Organization
Tohoku University Hospital
Division name
Hepato-Biliary Pancreatic surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
Homepage URL
http://www.surg1.med.tohoku.ac.jp/society/index.html
fmotoi@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Study group of preoperative therapy for pancreatic cancer (Prep)
Institute
Department
Personal name
Funding Source
Organization
None (Self-funding)
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
| 2010 | Year | 10 | Month | 01 | 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
| 2010 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | 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
| 2010 | Year | 09 | Month | 02 | Day |
Last modified on
| 2017 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004979
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
