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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name