UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010911 |
|---|---|
| Receipt number | 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 07:53:08 |
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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
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
mfujita@fukuoka-u.ac.jp
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
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
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
Value
https://center6.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 |
