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

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 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


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

Value
https://center6.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