UMIN-CTR Clinical Trial

Basic information
Public title	Prospective cohort study of neoadjuvant chemoradiotherapy using GEM and nabPTX for borderline resectable pancreatic cancer
Acronym	Prospective cohort study of neoadjuvant chemoradiotherapy using GEM and nabPTX for borderline resectable pancreatic cancer
Scientific Title	Prospective cohort study of neoadjuvant chemoradiotherapy using GEM and nabPTX for borderline resectable pancreatic cancer
Scientific Title:Acronym	Prospective cohort study of neoadjuvant chemoradiotherapy using GEM and nabPTX for borderline resectable pancreatic cancer
Region	Japan

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

Objectives
Narrative objectives1	To verify the resectability and the efficacy of neoadjuvant chemoradiotherapy using GEM and nabPTX which attempt curative resection for borderline resectable pancreatic cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Response 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	Neoadjuvant chemotherapy using GEM and nabPTX
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Cases diagnosed BRPC 2.Cases which chemotherapy and radiation were not performed 3.Over twenty years of age 4.Cases whose performance status at ECOG is from 0 to 1 5.Good organ function Neutrophil more than 1500, Platelet more than 100000, Hb more than 9, AST/ALT less than 7.5, T-Bil less than 2.0, Cr less than 1.5
Key exclusion criteria	1.Medical history of severe drug allergy 2.Cases which have severe complication 3.A pregnant woman, a woman who is probably pregnant, and a man who expect patner's pregnancy 4.Cases which have active infection with a fever over 38 degrees 5.Peripheral neuropathy more than grade 2
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ryutaro Mori
Organization	Yokohama city university graduate school of medicine
Division name	Department of gastroenterological surgery
Zip code
Address	3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004 Japan
TEL	045-787-2650
Email	ryutaromori@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Kentaro Miyake
Organization	Yokohama city university graduate school of medicine
Division name	Department of gastroenterological surgery
Zip code
Address	3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004 Japan
TEL	045-787-2650
Homepage URL
Email	miyekentarou@yahoo.co.jp

Sponsor
Institute	Department of gastroenterological surgery, Yokohama city university graduate school of medicine
Institute
Department

Funding Source
Organization	Department of gastroenterological surgery, Yokohama city university graduate school of medicine
Organization
Division
Category of Funding Organization	Self funding
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 07 Month 23 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	Terminated
Date of protocol fixation	2015 Year 07 Month 09 Day
Date of IRB	2015 Year 07 Month 23 Day
Anticipated trial start date	2015 Year 07 Month 23 Day
Last follow-up date	2020 Year 07 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	duration of therapy: one year follow-up period: three years

Management information
Registered date	2015 Year 07 Month 21 Day
Last modified on	2020 Year 08 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021240