UMIN-CTR Clinical Trial

Basic information
Public title	Prospective multicenter study regarding the efficacy of Gemcitabine (gemzar) plus nab-Paclitaxel (Abraxane) regimen for locally advanced pancreatic cancer
Acronym	GEAR study
Scientific Title	Prospective multicenter study regarding the efficacy of Gemcitabine (gemzar) plus nab-Paclitaxel (Abraxane) regimen for locally advanced pancreatic cancer
Scientific Title:Acronym	GEAR study
Region	Japan

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

Objectives
Narrative objectives1	To analyze the efficacy of Gemcitabine/nab-Paclitaxel regimen for locally advanced pancreatic cancer with arterial invasion
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	R0 resection rate
Key secondary outcomes	QOL assessment, Effectiveness of preoperative chemotherapy, pathological response rate, incidence rate of adverse events, relative dose intensity

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 Maneuver
Interventions/Control_1	Gemcitabine + nab-Paclitaxel regimen (Gemcitabine 1000mg/m2 nab-Panclitaxicel 125mg/2: day1,8,15 28day/course:2-4 course) and operation
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Histologically confirmed adenocarcinoma or adenosquamous carcinoma 2) BR-A pancreatic cancer 3) With measurable lesion(s) 4) Without distant metastasis 5) Without any further treatment for pancreatic cancer 6) Age more than 20 or less than 75 7)ECOG Performance Status 0-1 8) Without history of chemotherapy or radiotherapy 9)Adequate organ function 10) Sensory/motor neuropathy: None or Grade 1 11) Written informed consent
Key exclusion criteria	1) Present or previous (within 5 years) double cancer except for carcinoma in situ 2) Pregnant females, possibly pregnant females, females feeding babies and males wishing partners' pregnancy 3) Active infection 4) Severe mental disorder 5) Interstitial pneumonia or pulmonary fibrosis 6) Severe heart disease, liver disease and uncontrolled diabetes 7) Patients positive for HBs antigen 8) Patients inadequate for enhanced CT scan 9) Severe allergy for drugs 10) Patients with inadequate condition
Target sample size	37

Research contact person
Name of lead principal investigator	1st name Masafumi Middle name Last name Nakamura
Organization	Kyushu University
Division name	Department of Surgery and Oncology
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-622-5441
Email	mnaka@surg1.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Miyasaka
Organization	Kyushu University
Division name	Department of Surgery and Oncology
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-622-5441
Homepage URL
Email	yoshi-m@surg1.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu-Yamaguchi study group of therapy for pancreatobiliary cancer
Institute
Department

Funding Source
Organization	Self funding
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	Department of Surgery and Oncology, Kyushu University
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel	0926425441
Email	yoshi-m@surg1.med.kyushu-u.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 07 Month 01 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	37
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	2017 Year 06 Month 16 Day
Date of IRB	2017 Year 10 Month 13 Day
Anticipated trial start date	2017 Year 07 Month 20 Day
Last follow-up date	2020 Year 12 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 06 Month 15 Day
Last modified on	2020 Year 12 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031829

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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