UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006157 |
|---|---|
| Receipt number | R000007274 |
| Scientific Title | A Phase II Study of Cefepime Monotherapy for Febrile Neutropenia in Patients with Lung Cancer |
| Date of disclosure of the study information | 2011/08/12 |
| Last modified on | 2013/08/22 10:31:19 |
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Basic information
Public title
A Phase II Study of Cefepime Monotherapy for Febrile Neutropenia in Patients with Lung Cancer
Acronym
A Phase II Study of Cefepime Monotherapy for Febrile Neutropenia in Patients with Lung Cancer
Scientific Title
A Phase II Study of Cefepime Monotherapy for Febrile Neutropenia in Patients with Lung Cancer
Scientific Title:Acronym
A Phase II Study of Cefepime Monotherapy for Febrile Neutropenia in Patients with Lung Cancer
Region
| Japan |
Condition
Condition
Febrile neutropenia in patients with lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of cefepime monotherapy for febrile neutropenia in patients with lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate at the completion of cefepime treatment
Key secondary outcomes
Defervescence rate at 72 hours
Safety
Survival status at day 30
Detection rate of bacteria in blood using in situ hybridization method
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
Cefepime (1g every 8 hours intravenously) treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with lung cancer who are treated with chemotherapy or chemoradiotherapy
2) Fever defined as an axillary temperature 38 oC or greater
3) Neutropenia defined as an absolute neutrophil count of less than 500/mm3 or less than 1000/mm3 with provision to fall to less than 500/mm3 within the next 48 hours
4) ALT and AST less than 200 IU/L
Serum creatinine less than 2.0 mg/dL
5) Age of 18 years or older
6) Written informed consent
Key exclusion criteria
1) Infection in which the study drug is considered to be ineffective
2) Medical history of anaphylaxis or hypersensitivity to beta-lactams
3) Positive skin test to the study drug if skin testing is performed
4) Sings and symptoms of shock
5) Mycobacterial, fungal, rickettsial, viral, chlamydial, parasitic or protozoal infection
6) Prior history of antimicrobial therapy (prophylaxis with trimethoprin-sulfapethoxazole is excluded) within the past 14 days
7) Pregnant or nursing
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Saito |
Organization
Aichi Cancer Center Aichi Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, JAPAN
TEL
0564-21-6251
hsaito@acc-aichi.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Saito |
Organization
Aichi Cancer Center Aichi Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, JAPAN
TEL
0564-21-6251
Homepage URL
hsaito@acc-aichi.com
Sponsor or person
Institute
Central Japan Lung Study Group
Institute
Department
Personal name
Funding Source
Organization
Central Japan Lung Study Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
愛知県がんセンター愛知病院（愛知県）
NHO名古屋医療センター（愛知県）
JA愛知厚生連加茂病院（愛知県）
名古屋大学附属病院（愛知県）
公立陶生病院（愛知県）
名古屋掖済会病院（愛知県）
大垣市民病院（岐阜県）
豊橋市民病院（愛知県）
名古屋第一赤十字病院（愛知県）
トヨタ記念病院（愛知県）
NHO東名古屋病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | 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
| 2005 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 12 | Day |
Last modified on
| 2013 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007274
