UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility and efficacy of gemcitabine plus albumin-bound paclitaxel combination therapy (GEM+nabPTX therapy) in patients with borderline resectable pancreatic cancer in the neoadjvant setting.
Title of the study (Brief title)	Feasibility and efficacy of GEM+nabPTX therapy in patients with borderline resectable pancreatic cancer in the neoadjvant setting
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 evaluate feasibility and efficacy of GEM+nabPTX therapy in patients with borderline resectable pancreatic cancer in the neoadjvant setting
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	R0 resection rate
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 with GEM+nabPTX therapy followed by surgery
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) invasive ductal carcinoma of the pancreas 2) no distant metastasis 3) R0/1 resectable 4) borderline resectable Pancreatic cancer 5) all adult who anticipate to undergo pancreatectomy 6) no prior therapy 7) ECOG performance status of 0 or 1 8) adequate organ function 9) oral intake is possible 10) written informed consent
Key exclusion criteria	1) pulmonary fibrosis or interstitial pneumonitis 2) Active double cancer 3) Active infection 4) HBs antigen positive 5) patients are using flucytosine, phenytoin, warfarin 6) pregnant females, possibly pregnant females
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshihumi Beck
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Hepatobiliary Pancreatic Surgery
Address	1981 Kamoda, Kawagoe, Saitama, Japan
TEL	049-228-3400
Email	ybeck@saitama-med.ac.jp

Public contact
Name of contact person	Fumiaki Ozawa
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Hepatobiliary Pancreatic Surgery
Address	1981 Kamoda, Kawagoe, Saitama, Japan
TEL	049-228-3400
Homepage URL
Email	ozawa2@hotmail.com

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 04 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 20 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 20 Day
Last modified on	2016 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025354