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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027009
Receipt No. R000030964
Scientific Title Prospective, multicenter study for prediction of therapeutic effect of FOLFIRINOX with analyzing 5FU metabolism to aim the tailor-made therapy for unresectable pancreatic cancer.
Date of disclosure of the study information 2017/04/16
Last modified on 2017/04/16

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Basic information
Public title Prospective, multicenter study for prediction of therapeutic effect of FOLFIRINOX with analyzing 5FU metabolism to aim the tailor-made therapy for unresectable pancreatic cancer.
Acronym Prospective, multicenter study for prediction of therapeutic effect of FOLFIRINOX with analyzing 5FU metabolism to aim the tailor-made therapy for unresectable pancreatic cancer.
Scientific Title Prospective, multicenter study for prediction of therapeutic effect of FOLFIRINOX with analyzing 5FU metabolism to aim the tailor-made therapy for unresectable pancreatic cancer.
Scientific Title:Acronym Prospective, multicenter study for prediction of therapeutic effect of FOLFIRINOX with analyzing 5FU metabolism to aim the tailor-made therapy for unresectable pancreatic cancer.
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to select the more suitable pancreatic cancer patient for FOLFIRINOX therapy by measurement of UH2 and Uracil that have relationship with dihydropyrimidine dehydrogenase (DPD)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression free survival
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
80 years-old >
Gender Male and Female
Key inclusion criteria Histologically or cytologically proved pancreatic adenocarcinoma or adenosquamous carcinoma
Age 20-80 years
ECOG Performance Status (PS) 0-1
Unresectable 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,
Written informed consent
Key exclusion criteria 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 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironari Kato
Organization Okayama university hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama city, Japan
TEL 086-235-7221
Email katou-h@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Horiguchi
Organization Okayama university hospital
Division name Department of general medicine
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama city, Japan
TEL 086-235-7221
Homepage URL
Email horiguchis@gmail.com

Sponsor
Institute Okayama university hospital
Institute
Department

Funding Source
Organization Okayama university hospital
Organization
Division
Category of Funding Organization Other
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
2017 Year 04 Month 16 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
2017 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Before chemotherapy, we measure the concentration of ucacil and dihydrouracil in serum. After starting the chemotherapy, we perform regular examination and check the radiological image and make a study the relationship between metabolism of Uraci l and clinical data.

Management information
Registered date
2017 Year 04 Month 16 Day
Last modified on
2017 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030964

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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