UMIN-CTR Clinical Trial

Basic information
Public title	Observational study of neoadjuvant GS chemotherapy for patients with pancreatic cancer
Acronym	Neoadjuvant GS chemotherapy for pancreatic cancer
Scientific Title	Observational study of neoadjuvant GS chemotherapy for patients with pancreatic cancer
Scientific Title:Acronym	Neoadjuvant GS chemotherapy for pancreatic cancer
Region	Japan

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

Objectives
Narrative objectives1	Assesment of safety and efficacy of neoadjuvant chemotherapy using gemcitabine and S1 for patients with oancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety and efficacy of the neoadjuvant GS chemotherapy
Key secondary outcomes	Changes in tumour size and tumour markers, resection rate and R0 resection rate

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	Two cycles of neoadjuvant chemotherapy using Gemcitabine(100mg/m2,day1,day8) and S1(100mg/body or 120mg/body, day1-day14)
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)clinical diagnosis of pancreatic cancer 2)no distant metastasis 3)possible macroscopic curative resection 4)treatment naive 5)presence of measurable lesion 6)possible oral intake of S1 7)possible written informed consent 8)age not less than 20
Key exclusion criteria	1)patients with lung fibrosis and/or interstitial pneumoniae 2)unresectable SMA invasion 3)active double cancer 4)active infectious disease 5)creatinine clearance < 30mL/min
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Keiichi Middle name Last name Kubota
Organization	Dokkyo Medical University Hospital
Division name	Second department of surgery
Zip code	3210293
Address	Kitakobayashi 880, Mibu, Tochigi, Japan
TEL	0282861111
Email	kubotak@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Taku Middle name Last name Aoki
Organization	Dokkyo Medical University Hospital
Division name	Second department of surgery
Zip code	3210293
Address	Kitakobayashi 880, Mibu, Tochigi, Japan
TEL	0282861111
Homepage URL
Email	aoki-2su@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical University
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	Dokkyo Medical University
Address	880 Kitakobayashi, Mibu, Tochi 3210293 Japan
Tel	+81-282-86-1111
Email	aoki-2su@dokkyomed.ac.jp

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	2017 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results	Partially 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	No longer recruiting
Date of protocol fixation	2014 Year 02 Month 04 Day
Date of IRB	2014 Year 02 Month 04 Day
Anticipated trial start date	2014 Year 02 Month 04 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 14 Day
Last modified on	2020 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029539