UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective, multicenter study for prediction of therapeutic effect of FOLFIRINOX with analyzing 5FU metabolism to aim the tailor-made therapy for unresectable pancreatic cancer.
Title of the study (Brief 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.
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	Hironari Kato
Organization	Okayama university hospital
Division name	Department of Gastroenterology and Hepatology
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	Shigeru Horiguchi
Organization	Okayama university hospital
Division name	Department of general medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 04 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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