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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000016595
Receipt No. R000019258
Scientific Title A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer
Date of disclosure of the study information 2015/02/21
Last modified on 2016/11/04

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Basic information
Public title A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer
Acronym A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer
Scientific Title A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer
Scientific Title:Acronym A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer
Region
Japan

Condition
Condition unresectable pancreatic cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the feasibility of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes relative dose indensity
Key secondary outcomes neutropenia, febrile neutropenia, other adverse events(anemia, thrombocytopenia, anorexia, nausea, vommiting, diarrhea, peripheral sensory neuropathy), treatment cycles

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 The use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy
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

Not applicable
Gender Male and Female
Key inclusion criteria The inclusion criteria were: unresectable pancreatic cancer (locally advanced or metasitatic); an Eastern Cooperative Oncology Group PS of 0 or 1; adequate organ fuction (neutrophil count>2000/mm3, platelet count>10,000/mm3, total bilirubin <upper limit of normal*1.5); with written informed concent
Key exclusion criteria Patients are excluded if they have received prior chemotherapy or radiation therapy (
except for adjuvant chemotherapy); UGT genetic polymorphisms of homozygous UGT1A1*28 or UGT1A1*6 or heterozygous UTG1A1*6 and UGT1A1*28; diarrrhea including water stools; active infection or other serious concomitant diseases.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Ando
Organization Nagoya University Hospital
Division name Department of Clinical Oncology and Chemotherapy
Zip code
Address 65 Tsuruma-Cho, Showa-Ku, Nagoya, Japan
TEL 052-744-1903
Email yando@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayumu Matsuoka
Organization Nagoya University Hospital
Division name Department of Clinical Oncology and Chemotherapy
Zip code
Address 65 Tsuruma-Cho, Showa-Ku, Nagoya, Japan
TEL 052-744-1903
Homepage URL
Email ayumu0611@med.nagoya-u.ac.jp

Sponsor
Institute Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Institute
Department

Funding Source
Organization Management Expenses Grants
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
2015 Year 02 Month 21 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
Date of protocol fixation
2015 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 04 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
2015 Year 02 Month 21 Day
Last modified on
2016 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019258

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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