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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014711
Receipt No. R000010438
Scientific Title Garenoxacin to Prevent Febrile Neutropenia in Chemotherapy for Lung Cancer
Date of disclosure of the study information 2014/07/30
Last modified on 2014/12/11

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Basic information
Public title Garenoxacin to Prevent Febrile Neutropenia in Chemotherapy for Lung Cancer
Acronym Garenoxacin to Prevent Febrile Neutropenia in Chemotherapy for Lung Cancer
Scientific Title Garenoxacin to Prevent Febrile Neutropenia in Chemotherapy for Lung Cancer
Scientific Title:Acronym Garenoxacin to Prevent Febrile Neutropenia in Chemotherapy for Lung Cancer
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of secondary prophylactic garenoxacin for febrile neutropenia in chemotherapy of lung cancer, evaluated by the incidence of fever.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The incidence of clinically documented febrile episode
Key secondary outcomes The incidence of all probable infections
The site of infection
Pathogenic bacteria
The incidence of death
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 Prevention
Type of intervention
Medicine
Interventions/Control_1 In lung cancer patients who had febrile neutropenia in the privious chemotherapy, garenoxacin is prescribed in the next cycle of chemotherapy from day 8 for 1 week or until grade 2 neutropenia to prevent febrile neutropenia.
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 1)Patients with lung cancer during chemotherapy
2)Patients who experienced febrile neutropenia
3)Dose of chemotherapy is not changed in the next cycle of the therapy.
4)Age: over 20
5)Adequate organ functions judged by laboratory tests.
6)Life expectancy: longer than 3 months
7)Wrtten informed consent
Key exclusion criteria 1)Tumor fever
2)Complication such as severe infection or comobidities
3)History of severe allergic reaction
4)History of epilepsy or convulsant
5)Clinically significant heart disease
6)Uncontrolled diabetes
7)Routine use of NSAIDS
8)Routine use of steroids or immuno-suppressant
9)Chronic aspiration
10)Clinically significant psychological problems
11)unsuitable patients whom physitians consider
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Katakami
Organization Institute of Biomedical Research and Innovation
Division name Division of Integrated Oncology
Zip code
Address 2-2, Minatojima-minamimachi, Cho-ku, Kobe
TEL 078-304-5200
Email katakami@fbri.org

Public contact
Name of contact person
1st name
Middle name
Last name Akito Hata
Organization Institute of Biomedical Research and Innovation
Division name Division of Integrated Oncology
Zip code
Address 2-2, Minatojima-minamimachi, Cho-ku, Kobe
TEL 078-304-5200
Homepage URL
Email a-hata@fbri.org

Sponsor
Institute Institute of Biomedical Research and Innovation
Institute
Department

Funding Source
Organization Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 先端医療センター(兵庫県)Institute of Biomedical Research and Innovation
神戸市立医療センター中央市民病院(兵庫県)Kobe Medical Center General Hospital

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 30 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 Completed
Date of protocol fixation
2010 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2014 Year 07 Month 31 Day
Date of closure to data entry
2014 Year 07 Month 31 Day
Date trial data considered complete
2014 Year 08 Month 31 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 30 Day
Last modified on
2014 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010438

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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