UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of sitafloxacin (STFX) for low-risk febrile neutropenia in patients with lung cancer, phase II study,
Title of the study (Brief title)	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	Masaki Fujita
Organization	Fukuoka University, Faculty of Medicine
Division name	Department of Respiratory Medicine
Address	7-45-1 Nanakuma, Jonanku, Fukuoka
TEL	092-801-1011
Email	mfujita@fukuoka-u.ac.jp

Public contact
Name of contact person	Masaki Fujita
Organization	Fukuoka University, Faculty of Medicine
Division name	Department of Respiratory Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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