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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013217
Receipt No. R000015423
Scientific Title Feasibility study of FOLFIRINOX as first-line chemotherapy for metastatic pancreatic cancer
Date of disclosure of the study information 2014/02/25
Last modified on 2016/09/13

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Basic information
Public title Feasibility study of FOLFIRINOX as first-line chemotherapy for metastatic pancreatic cancer
Acronym KOBE FOLFIRINOX study
Scientific Title Feasibility study of FOLFIRINOX as first-line chemotherapy for metastatic pancreatic cancer
Scientific Title:Acronym KOBE FOLFIRINOX study
Region
Japan

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

Objectives
Narrative objectives1 Determining the maximum tolerated dose (MTD) and recommended dose (RD)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Proportion of dose limiting toxicity
Key secondary outcomes safety (adverse event, completion rate), efficacy (overall survival, progression free survival, response rate)

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 FOLFIRINOX
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Unresectable metastatic or recurrence pancreatic cancer
2) Histlogically proven adenocarcinoma
3) Age >= 18 years
4) ECOG performance status of 0, 1
5) Previous adjuvant chemotherapy was allowed if relapsed more than 6 months after last administration
6) UGT1A1*6*28 wild type or single hetero
7) No prior chemotherapy and radiotherapy for other malignancies
8) Adequate bone marrow, hepatic, renal, cardiac and respiratory functions
9) Written informed consent
Key exclusion criteria 1) active synchronous or metachronous malignancy other than carcinoma in situ
2) pregnant or nursing
3) severe mental disorders
4) systemic steroid user
5) diabetes mellitus, uncontrolled
6) history of myocardial infarction, unstable angina within 3 months prior to the registration
7) serious coexisting illness
8) active infection
9) peripheral neuropathy greater than Grade 2
10) diarrhea greater than Grade 2
11) ileus
12) massive pleural effusion,ascites
13) history for allergy of L-OHP,CPT-11,5-FU,L-LV,bevacizumab
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihito Tsuji
Organization Kobe City Medical Center General Hospital
Division name medical oncology
Zip code
Address 2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL 0783024321
Email hsatake@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironaga Satake
Organization Kobe City Medical Center General Hospital
Division name medical oncology
Zip code
Address 2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL 0783024321
Homepage URL
Email hsatake@kcho.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

Funding Source
Organization Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization Local Government
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 神戸市立医療センター中央市民病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2014 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
2014 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 25 Day
Last follow-up date
2015 Year 07 Month 31 Day
Date of closure to data entry
2016 Year 07 Month 31 Day
Date trial data considered complete
2016 Year 07 Month 31 Day
Date analysis concluded
2016 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 21 Day
Last modified on
2016 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015423

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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