UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011064 |
|---|---|
| Receipt number | R000012945 |
| Scientific Title | Neoadjuvant chemotherpy with gemcitabine and oral S-1for pancreatic cancer |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2016/06/28 10:59:28 |
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Basic information
Public title
Neoadjuvant chemotherpy with gemcitabine and oral S-1for pancreatic cancer
Acronym
NAC with GEM+S-1
Scientific Title
Neoadjuvant chemotherpy with gemcitabine and oral S-1for pancreatic cancer
Scientific Title:Acronym
NAC with GEM+S-1
Region
| Japan |
Condition
Condition
resectable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Estimation of the recommended dose of GEM + S-1 combination therapy as preoperative chemotherapy for pancreatic cancer surgery patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Determination of the recommended dose
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
preoperative chemotherapy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Resectable pancreatic cancer without severe complications
Key exclusion criteria
1) Patients with anti-cancer agent administration in history past
2) Active another cancer
3) Severe complications
4) Patients with interstitial pneumonia or pulmonary fibrosis
5) Active infection
6) Pregnant woman
7) Severe mental disorder
8) Others
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Ohta |
Organization
Kanazawa University
Division name
Gastroenterological Surgery
Zip code
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2362
hidetaji@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidehiro Tajima |
Organization
Kanazawa University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery
Zip code
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2362
Homepage URL
hidetaji@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterologic Surgery, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
None.
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
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
| 2013 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2009 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | 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
| 2013 | Year | 06 | Month | 28 | Day |
Last modified on
| 2016 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012945
| 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 |
