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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011064
Receipt No. 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

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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
Email 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
Email hidetaji@staff.kanazawa-u.ac.jp

Sponsor
Institute Department of Gastroenterologic Surgery, Kanazawa University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012945

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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