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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016630
Receipt No. R000018969
Scientific Title The phaseI,II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with locally-advanced pancreatic cancer
Date of disclosure of the study information 2015/02/25
Last modified on 2016/01/22

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Basic information
Public title The phaseI,II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with locally-advanced pancreatic cancer
Acronym GAS Study I/II
Scientific Title The phaseI,II study of neoadjuvant chemotherapy of gemcitabine+nab-paclitaxel+S-1 for patients with locally-advanced pancreatic cancer
Scientific Title:Acronym GAS Study I/II
Region
Japan

Condition
Condition locally-advanced pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of gemcitabine+nab-paclitaxel+S-1(GAS)therapy as a neoadjuvant therapy for locally-advanced pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: incidence of adverse enent which apply for discontinuance criteria
Phase II: 2 year survival rate, median survival time
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 gemcitabine+nab-paclitaxel+S-1
gemcitabine
(Level I:800mg/m2)
(Level II:1000mg/m2)
nab-paclitaxel
(Level I:100mg/m2)
(Level II:125mg/m2)
S-1 (65mg/m2)
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 (1)Histologically confirmed pancreatic cancer
(2)Locally advanced pancteatic cancer on imaging examinations
(3)Performance status(ECOG):0-1
(4)Initial therapy
(5)Agreement with signiture of aplicant has obtained before initiation of therapy
Key exclusion criteria (1)severe allegy for medicine
(2)Patients with other malignant disease within 5 years
(3)Patients with active infection
(4)Patients with severe neuropathy(>Grade2)
(5)Patients with ileus
(6)Patients with interstitial pneumonia
(7)Patients with uncontrallable ascites or pleural fluid
(8)Patients with uncontrallable diabetes
(9)Patients with uncontrallable heart disease
(10)Patients with pregnant or possibly pregnant
(14)Patients who have judged not suitable for this study by doctor.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Murakami
Organization Hiroshima University
Division name Institute of Biomedical and Health Sciences Applied Life Sciences Surgery
Zip code
Address Kasumi,Minami-Ku, Hiroshima, JAPAN
TEL 082-257-5215
Email k-naru-surg@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naru Kondo
Organization Hiroshima University
Division name Institute of Biomedical and Health Sciences Applied Life Sciences Surgery
Zip code
Address Kasumi,Minami-Ku, Hiroshima, JAPAN
TEL 082-257-5215
Homepage URL
Email k-naru-surg@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization No
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
2015 Year 02 Month 25 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 Open public recruiting
Date of protocol fixation
2015 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 27 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
2015 Year 02 Month 25 Day
Last modified on
2016 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018969

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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