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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005275
Receipt No. R000006234
Scientific Title Effect of cefepime (CFPM) or meropenem (MEPM) for febrile neutropenia patients with lung cancer. Randomized phase II study.
Date of disclosure of the study information 2011/03/18
Last modified on 2013/03/26

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Basic information
Public title Effect of cefepime (CFPM) or meropenem (MEPM) for febrile neutropenia patients with lung cancer. Randomized phase II study.
Acronym Febrile neutropenia patients with lung cancer. CFPM vs MEPM
Scientific Title Effect of cefepime (CFPM) or meropenem (MEPM) for febrile neutropenia patients with lung cancer. Randomized phase II study.
Scientific Title:Acronym Febrile neutropenia patients with lung cancer. CFPM vs MEPM
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 cefepime or meropenem for febrile neutropenia in lung cancer patients by prospective randomized study.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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 Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of antibiotics (Cefepime)
Interventions/Control_2 Administration of antibiotics (Meropenem)
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 <1000/mm3 and a temperature of >= 37.5
Key exclusion criteria 1. Patient who is too severely ill
2. A history of cardiac failure, renal failure, or liver damage.
3. A known history of hypersensitivity to cephalosporins
4. A known history of allergy
5. Patient who demonstrated positive for skin reaction test ( if skin reaction test was done)
6. Patient who is not evaluated for response
7. Pregnant or lactating women.
8. Patient administered with sodium valproate
9. Patients administered with prohibiting medication (such as other antibiotics, gamma-globulin, corticosteroid, furosemide)
10.patient who is judged as an inappropriate case by the doctor in charge
Target sample size 46

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

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

Sponsor
Institute LOGIK(Lung oncology group in Kyushu)
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 福岡大学病院(福岡県)
済生会飯塚嘉穂病院(福岡県)
飯塚病院(福岡県)
九州大学(福岡県)
済生会福岡総合病院(福岡県)
産業医科大学(福岡県)
浜の町病院(福岡県)
福岡大学筑紫病院(福岡県)
国立病院機構福岡病院(福岡県)
原三信病院(福岡県)
大分大学(大分県)
熊本大学(熊本県)
健康保険諫早総合病院(長崎県)
長崎大学病院(長崎県)
国立病院機構岩国医療センター(山口県)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 18 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 12 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2013 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 18 Day
Last modified on
2013 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006234

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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