UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of gemcitabine plus nab-Pacletaxel as second-line therapy after FOLFIRINOX for advanced pancreatic cancer
Acronym	2nd-line nab-Ptx+Gem study
Scientific Title	Phase II study of gemcitabine plus nab-Pacletaxel as second-line therapy after FOLFIRINOX for advanced pancreatic cancer
Scientific Title:Acronym	2nd-line nab-Ptx+Gem study
Region	Japan

Condition
Condition	advanced 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 second-line nab-Paclitaxel and Gemcitabin after FOLFIRINOX in inoperable pancreatic cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Overall survival Progression free survival The frequency of occurrence of complication

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
Interventions/Control_1	2nd-line nab-Ptx+Gem study
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	Histological or cytologically proved pancreatic cancer adenocarcinoma or adenosquamous carcinoma Inoperative cases of advanced pancreatic cancer Second-line chemotherapy for pancreatic cancer after FOLFIRINOX Age 20-75 years ECOG Performance Status (PS) 0-1 Meets the following criteria within 14 days before enrollment WBC count <12,000/microl, absolute neutrophil count >1,500/microl, platelet count >100,000/microl, hemoglobin >9g/dl, bilirubin <2.0mg/dl, AST and ALT <150U/l, Creatinine <1.5mg/dl, Creatinine clearance test >50ml/min Without anorexia Without peripheral neuropathy Normal ECG An agreement is provided
Key exclusion criteria	Pulmonary fibrosis or interstitial pneumonia Watery stool Infection Uncontrolled diabetes mellitus Any serious complication Pregnancy
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takuji Iwashita
Organization	Gifu University Hospital
Division name	First Department of internal Medicine
Zip code
Address	1-1 Yanagido, Gifu city, Gifu
TEL	058-230-6308
Email	takuji@w7.dion.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Mitsuru Okuno
Organization	Gifu University Hospital
Division name	First Department of internal Medicine
Zip code
Address	1-1 Yanagido, Gifu city, Gifu
TEL	058-230-6308
Homepage URL
Email	mkobdkl@yahoo.co.jp

Sponsor
Institute	Gifu University Hospital
Institute
Department

Funding Source
Organization	Gifu University Hospital, First Department of internal Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Gastroenterology, Gifu Municipal Hospital Department of Gastroenterology, Gifu Prefectural General Medical Center
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 02 Month 25 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 02 Month 25 Day
Date of IRB	2015 Year 02 Month 25 Day
Anticipated trial start date	2015 Year 02 Month 25 Day
Last follow-up date	2018 Year 02 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 02 Month 25 Day
Last modified on	2022 Year 09 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019304