UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014711 |
|---|---|
| Receipt number | 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 15:11:04 |
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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
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
a-hata@fbri.org
Sponsor or person
Institute
Institute of Biomedical Research and Innovation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010438
