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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010911
Receipt No. R000012769
Scientific Title Efficacy and safety of sitafloxacin (STFX) for low-risk febrile neutropenia in patients with lung cancer, phase II study,
Date of disclosure of the study information 2013/06/12
Last modified on 2018/03/29

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Basic information
Public title Efficacy and safety of sitafloxacin (STFX) for low-risk febrile neutropenia in patients with lung cancer, phase II study,
Acronym STFX for low risk febrile neutropenia
Scientific Title Efficacy and safety of sitafloxacin (STFX) for low-risk febrile neutropenia in patients with lung cancer, phase II study,
Scientific Title:Acronym STFX for low risk febrile neutropenia
Region
Japan

Condition
Condition febrile neutropenia
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to determine the efficacy and safety of sitafloxacin for low risk febrile neutropenia in lung cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Defervescence at 72 hours, 7 days, 14 days
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 Administration of antibiotics (sitafloxacin)
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.Informed consent is obtained
2.Patient who is judged as an appropriate case by the doctor in charge
3.At least 20 years of age
4. Patient who had lung cancer accompanied by chemotherapy-induced neutropenia with a polymorphonuclear neutrophil count of less than 1000/mm3 and a temperature of 37.5 C
MASCC score of 21 or above
Key exclusion criteria 1. Patient who is too severely ill
2. A history of renal failure (S-Cr of 2.0 mg/dl or above)
3. A known history of hypersensitivity to fluoroquinolones
4. A known history of allergy
5. Patient who is not evaluated for response
6. Pregnant or lactating women.
7. Patients administered with prohibiting medication (such as other antibiotics, gamma-globulin, corticosteroid)
8.patient who is judged as an inappropriate case by the doctor in charge
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Fujita
Organization Fukuoka University, Faculty of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 7-45-1 Nanakuma, Jonanku, Fukuoka
TEL 092-801-1011
Email mfujita@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Fujita
Organization Fukuoka University, Faculty of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 7-45-1 Nanakuma, Jonanku, Fukuoka
TEL 092-801-1011
Homepage URL
Email mfujita@fukuoka-u.ac.jp

Sponsor
Institute Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization JAPAN

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 飯塚病院(福岡県)
鹿児島厚生連病院(鹿児島県)
九州大学(福岡県)
九州労災病院(福岡県)
熊本大学(熊本県)
熊本地域医療センター(熊本県)
健康保険諫早総合病院(長崎県)
国立病院機構大牟田病院(福岡県)
国立病院機構沖縄病院(沖縄県)
国立病院機構福岡東医療センター(福岡県)
済生会飯塚嘉穂病院(福岡県)
佐賀県医療センター好生館(佐賀県)
産業医科大学(福岡県)
十善会病院(長崎県)
新別府病院(大分県)
製鉄記念八幡病院(福岡県)
浜の町病院(福岡県)
原三信病院(福岡県)
福岡青州会病院(福岡県)
福岡赤十字病院(福岡県)
福岡大学(福岡県)
福岡大学筑紫病院(福岡県)
琉球大学(沖縄県)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 12 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
2013 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 17 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 09 Day
Last modified on
2018 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012769

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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