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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00003739




Registration number
NCT00003739
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
14/02/2014

Titles & IDs
Public title
Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
Scientific title
Randomized Comparison Between Antibiotics Alone and Antibiotics Plus Granulocyte-Colony Stimulating Factor in Pediatric Patients With Chemotherapy Induced Febrile Neutropenia
Secondary ID [1] 0 0
COG-AS973
Secondary ID [2] 0 0
AS973
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fever, Sweats, and Hot Flashes 0 0
Neutropenia 0 0
Unspecified Childhood Solid Tumor, Protocol Specific 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - filgrastim

Other interventions: filgrastim


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Resolution of Febrile Neutropenia - Time to Resolution of Febrile Neutropenia (Days of antibiotic treatment until the resolution of febrile neutropenia): The time to resolution of febrile neutropenia is defined as the number of days elapsed before the first day with both a temperature of less than 38.0oC and an ANC of equal to or greater than 500/µL.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Incidence of Change of the Initial Empiric Antibiotic Treatment - The Incidence of Change of the Initial Empiric Antibiotic Treatment: Any change in the initial empiric broad spectrum antibiotic treatment made during the febrile neutropenia period. There may be changes made in the antibiotic(s) after the resolution of febrile neutropenia.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically diagnosed cancer with fever and chemotherapy-induced neutropenia
(absolute neutrophil count no greater than 500/mm3)

- Acute onset of fever of at least 38.8 degrees Celsius that is not related to the
administration of blood products or pyrogenic substances

- No acute myelogenous leukemia

- No myelodysplastic syndrome

- No solid tumor with bone marrow involvement

PATIENT CHARACTERISTICS:

Age:

- 21 and under

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Creatinine less than 1.5 times upper limit of normal

Renal:

- Not specified

Other:

- No patients in septic shock

- No prolonged fever of unknown origin

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

- See Chemotherapy

Chemotherapy:

- No prior or concurrent myeloablative chemoradiotherapy with bone marrow or peripheral
stem cell rescue

Endocrine therapy:

- Not specified

Radiotherapy:

- See Chemotherapy

- No prior radiotherapy to marrow reserves (i.e., craniospinal and/or pelvic
irradiation)

Surgery:

- Not specified

Other:

- At least 7 days since prior IV antibiotics
Minimum age
No limit
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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Washington
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West Virginia
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Wisconsin
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Alberta
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British Columbia
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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Nova Scotia
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Ontario
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Saskatchewan
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Groningen
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Auckland
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San Juan
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Santurce
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Bern
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Geneva
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Switzerland
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Lausanne

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Antibiotics may decrease the side effects of neutropenia and fever caused by
chemotherapy. Colony-stimulating factors such as G-CSF may increase the number of immune
cells found in bone marrow or peripheral blood and may help a person's immune system recover
from the side effects of chemotherapy. It is not yet known whether antibiotic therapy plus
G-CSF is more effective than antibiotic therapy alone for treating side effects caused by
chemotherapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of antibiotic therapy with
or without G-CSF in treating children who have neutropenia and fever that are caused by
chemotherapy.
Trial website
https://clinicaltrials.gov/show/NCT00003739
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
M. F. Ozkaynak, MD
Address 0 0
New York Medical College
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications