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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013301
Receipt No. R000015456
Scientific Title Phase II trial of modified FOLFIRINOX (irinotecan plus oxaliplatin and 5-fluorouracil/leucovorin) in patients with untreated metastatic pancreatic cancer
Date of disclosure of the study information 2014/02/28
Last modified on 2015/01/26

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Basic information
Public title Phase II trial of modified FOLFIRINOX (irinotecan plus oxaliplatin and 5-fluorouracil/leucovorin) in patients with untreated metastatic pancreatic cancer
Acronym modified FOLFIRINOX
Scientific Title Phase II trial of modified FOLFIRINOX (irinotecan plus oxaliplatin and 5-fluorouracil/leucovorin) in patients with untreated metastatic pancreatic cancer
Scientific Title:Acronym modified FOLFIRINOX
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of modified FOLFIRINOX in metastatic pancreatic cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes overall survival
Key secondary outcomes

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 modified 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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Histologically or cytologically proved pancreatic adenocarcinoma or adenosquamous carcinoma
Age 20-75 years
ECOG Performance Status (PS) 0-1
Metastatic pancreatic cancer with measurable lesion according to RECIST ver.1.1
Meets the following criteria within 7days before enrollment
absolute neutrophil count<2,000/uL, platelet count<100,000/uL, hemoglobin<9 g,/dL, white blood cell count<10,000/uL, bilirubin < ULN, AST and ALT < 2.5 X ULN, CRP<2.0mg/dl
Written informed consent
Key exclusion criteria Prior radiotherapy or chemotherapy
Homotype of UGT1A1 genotype including *28/*28, *6/*6 and*6/*28
Evident pleural effusion, ascites, pericardial effusion or peritoneal metastasis on CT before enrollment
Pulmonary fibrosis or interstitial pneumonia
Watery stool within 3 days before enrollment
Uncontrolled diabetes mellitus
Any serious complication
Target sample size 65

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ishii
Organization Cancer Institute Hospital
Division name Department of Gastroenterology
Zip code
Address 3-8-31 Ariake, Koto-ward, Tokyo
TEL 03-3520-0111
Email hiroshi.ishii@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masato Ozaka
Organization Cancer Institute Hospital
Division name Department of Gastroenterology
Zip code
Address 3-8-31 Ariake, Koto-ward, Tokyo
TEL 03-3520-0111
Homepage URL
Email masato.ozaka@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital
Institute
Department

Funding Source
Organization National Cancer Center Hospital
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 28 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 No longer recruiting
Date of protocol fixation
2013 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 28 Day
Last modified on
2015 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015456

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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