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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020801
Receipt No. R000023993
Scientific Title A phase II study of FOLFIRINOX in patients with advanced biliary tract cancer
Date of disclosure of the study information 2016/02/01
Last modified on 2018/08/01

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Basic information
Public title A phase II study of FOLFIRINOX in patients with advanced biliary tract cancer
Acronym FOLFIRINOX for advanced biliary tract cancer
Scientific Title A phase II study of FOLFIRINOX in patients with advanced biliary tract cancer
Scientific Title:Acronym FOLFIRINOX for advanced biliary tract cancer
Region
Japan

Condition
Condition Biliary tract cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the safety and the efficacy of FOLFIRINOX in patients with advanced biliary tract cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Response rate, disease control rate,
overall survival, and safety

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 FOFIRINOX which is a combination chemotherapy of oxaliplatin, irinotecan, leucovorin, and fluorouracil will be given every 2 weeks.
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 1) unresectable or recurrent biliary tract cancer
2) histologically or cytologically confirmed adenocarcinoma
3) no prior chemotherapy or radiation therapy
4) age of 20-75 years
5) an Eastern Cooperative Oncology Group PS of 0 or 1
6) at least one measurable lesion
7) adequate hematological, liver, and renal function (white blood cell count=> 10 000/mm3, neutrophil count=>2000/mm3, hemoglobin=>9.0 g/dL, platelet count=>100 000/mm3, aspartate transaminase and alanine transaminase <=2.5x upper limit of normal, total bilirubin <=1.2x upper limit of normal, Creatinine clearance =>50 ml/min).
8) written informed consent
Key exclusion criteria 1) synchronous or metachronous double cancer, excluding carcinoma in situ or intramucosal carcinoma cured by local treatment
2) allergy for contrast medium for CT and MRI
3) brain metastasis
4) blood transfusion, blood products, or hematopoietic growth factor preparations such as G-CSF within 7 days before enrollment
5) UGT genetic polymorphisms of homozygous UGT1A1*28 or UGT1A1*6 or heterozygous UGT1A1*6 and UGT1A1*28
6) apparent coelomic fluid (pleural effusion, ascites, or pericardial fluid)
7) serious concomitant diseases
8) abnormal findings in ECG
9) intestinal pneumonia
10) poorly controlled diabetes
11) diarrhea including watery stools within 3 days before enrollment
12) grade 2 or higher peripheral sensory neuropathy
13) active infection other than HBV or HCV
14) serious allergy
15) history of severe drug allergy
16) pregnant or lactating woman
17) disqualified for trial by principal investigator.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yousuke Nakai
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email ynakai-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naminatsu Takahara
Organization The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-5800-9119
Homepage URL
Email naminatsu-takahara@umin.ac.jp

Sponsor
Institute Department of Gastroenterology, Graduate school of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
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 京都大学病院(京都府)、大阪国際がんセンター(大阪府)、がん研有明病院、杏林大学

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 01 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
2016 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 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
2016 Year 01 Month 29 Day
Last modified on
2018 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023993

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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