UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2015 Year 01 Month 10 Day
Date of IRB	2015 Year 03 Month 25 Day
Anticipated trial start date	2015 Year 03 Month 27 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 11 Month 30 Day

Other
Other related information

Management information
Registered date	2015 Year 02 Month 25 Day
Last modified on	2022 Year 09 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018969