UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027009 |
|---|---|
| Receipt number | 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 22:06:25 |
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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
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
horiguchis@gmail.com
Sponsor or person
Institute
Okayama university hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030964
