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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034509
Receipt No. R000039348
Scientific Title Feasibility and efficacy of FOLFIRINOX therapy in patients with borderline resectable pancreatic cancer in the neoadjvant setting.
Date of disclosure of the study information 2018/11/01
Last modified on 2019/04/15

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Basic information
Public title Feasibility and efficacy of FOLFIRINOX therapy in patients with borderline resectable pancreatic cancer in the neoadjvant setting.
Acronym Feasibility and efficacy of FOLFIRINOX therapy in patients with borderline resectable pancreatic cancer in the neoadjvant setting
Scientific Title Feasibility and efficacy of FOLFIRINOX therapy in patients with borderline resectable pancreatic cancer in the neoadjvant setting.
Scientific Title:Acronym Feasibility and efficacy of FOLFIRINOX 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 FOLFIRINOX 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 overall survival
Key secondary outcomes recurrence free survival, R0 resection rate

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 FOLFIRINOX therapy followed by radical 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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 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) Chemotherapy naiive for pancreatic cancer
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
1st name
Middle name
Last name Yoshifumi Beck
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Hepatobiliary Pancreatic Surgery
Zip code
Address 1981 Kamoda, Kawagoe, Saitama, Japan
TEL 049-228-3400
Email ybeck@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Riki Ninomiya
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Hepatobiliary Pancreatic Surgery
Zip code
Address 1981 Kamoda, Kawagoe, Saitama, Japan
TEL 049-228-3400
Homepage URL
Email rickynino9222@gmail.com

Sponsor
Institute Department of Hepatobiliary Pancreatic Surgery, Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Department of Hepatobiliary Pancreatic Surgery, 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)

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 埼玉医科大学総合医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
2019 Year 01 Month 01 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2022 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
2018 Year 10 Month 15 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039348

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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