UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Acronym	Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Scientific Title	Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Scientific Title:Acronym	Phase II study of Gemcitabine + nab-paclitaxel as first-line therapy for locally advanced pancreatic cancer
Region	Japan

Condition
Condition	locally advanced unresectable pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of first line GEM+ nab-PTX combination therapy for locally advanced pancreatic cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Overall survival, progression free survival, adverse events

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	Patients receiving nab-PTX plus gemcitabine will receive 125 mg/m2, nab-PTX as a 30- to 40-minute infusion (maximum infusion time not to exceed 40 minutes) followed by 1000 mg/m2 gemcitabine as a 30- to 40-minute infusion (maximum 40 minutes) for 3 weeks followed by a week of rest.
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) Histlogically proven adenocarcinoma or adeno-squamous carcinoma 2) Unresectable locally advanced pancreatic cancer 3) No prior chemotherapy and radiotherapy for other malignancies 4) Age upper 20 and less than 80 5) ECOG performance status of 0, 1 6) Adequate hematologic, hepatic and renal function 7) Written informed consent
Key exclusion criteria	1) Patients with Distant metastasis 2) Patients with symptomatic pulmonary fibrosis or interstitial pneumonia 3) Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 4) Patients has severe complications, such as heart failure, renal failure ileus and severe mental disorder 5) History of malignancy in the last 3 years 6) History of Peripheral Artery Disease (eg, claudication, Leo Buerger's disease). 7) History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa). 8) Women who are pregnant or expect to be pregnant, or nursing female 9) Others
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Takuji Middle name Last name Torimura
Organization	Kurume university school of medicine
Division name	Division of gastroenterology
Zip code	8300011
Address	Kurume-shi
TEL	0942-31-7561
Email	takahashi_kenjirou@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Masaru Middle name Last name Fukahori
Organization	Kurume university school of medicine
Division name	Division of gastroenterology, multidisciplinary cancer treatment center
Zip code	830-0011
Address	67 Asahi-machi, Kurume city, Fukuoka
TEL	0942-31-7561
Homepage URL
Email	digdug0526@gmail.com

Sponsor
Institute	Kurume university school of medicine
Institute
Department

Funding Source
Organization	None
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	The Ethical Committee of Kurume University
Address	67 Asahi-machi, Kurume city, Fukuoka
Tel	0942-31-7917
Email	aro_crc@kurume-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	久留米大学病院(福岡県)

Other administrative information
Date of disclosure of the study information	2015 Year 03 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	Completed
Date of protocol fixation	2015 Year 03 Month 20 Day
Date of IRB	2015 Year 03 Month 16 Day
Anticipated trial start date	2015 Year 03 Month 23 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 04 Month 03 Day

Other
Other related information

Management information
Registered date	2015 Year 03 Month 20 Day
Last modified on	2020 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019542

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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