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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016624
Receipt No. R000019304
Scientific Title Phase II study of gemcitabine plus nab-Pacletaxel as second-line therapy after FOLFIRINOX for advanced pancreatic cancer
Date of disclosure of the study information 2015/02/25
Last modified on 2016/08/27

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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 Open public recruiting
Date of protocol fixation
2015 Year 02 Month 25 Day
Date of IRB
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
2016 Year 08 Month 27 Day


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

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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