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Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy

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ClinicalTrials.gov Identifier: NCT01571518
Recruitment Status : Unknown
Verified April 2012 by Hyuk moon Kim, Sunchonhang University.
Recruitment status was:  Not yet recruiting
First Posted : April 5, 2012
Last Update Posted : April 5, 2012
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Hyuk moon Kim, Sunchonhang University

Study Description
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Brief Summary:
After resection of lymph node positive breast cancer, the injection duration and timing of Granulocyte-colony stimulating factor (G-CSF) could affect the neutropenia with TAC (Taxotere, Adriamycin, cyclophosphamide) chemotherapy.

Condition or disease Intervention/treatment Phase
Neutropenia Drug: late leukostim Drug: early leukostim Phase 4

Detailed Description:
The duration and the injection timing of G-CSF are effective in the prevention of neutropenia, incidence of infection and non hematologic toxicity. With the TAC chemotherapy after resection of breast cancer, the G-CSF early injection versus late injection could change the frequency of neutropenia.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimal Timing and Duration of Daily G-CSF With Adjuvant TAC Chemotherapy in Node-positive Breast Cancer;Multicenter, Randomized, Open Label, Clinically IV Phase
Study Start Date : April 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: early injection
injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy
 Drug: late leukostim
injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy
Other Name: 5leuko
Sham Comparator: late injection
injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy
 Drug: early leukostim
injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy
Other Name: 2leuko


Outcome Measures
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Primary Outcome Measures :
  1. frequency of neutropenia [ Time Frame: Change from Baseline in neutrophil count at 21days ]
    during the 1 cycle (21days) of ajuvant chemotherapy with TAC, record the frequency of neutropenia aftr using G-CSF (Leucostim)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary invasive breast carcinoma with lymph node positive with curative surgery with TAC chemotherapy

Exclusion Criteria:

  • pregnancy,
  • cardiovascualr disease,
  • abnormal renal function,
  • hematologic disorder
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571518


Contacts
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Contact: Chul Wan Lim, M.D., Ph.D 82-32-621-5114 cylim@soonchunhyang.com

Locations
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Korea, Republic of
Soonchunhyang university Puchun Hospital
Puchun, Korea, Republic of
Contact: Hyuk moon Kim, MD    82-32-621-5114    hmkim@soonchunhyang.com   
Principal Investigator: ChulWan Lim, MD.PhD         
Sponsors and Collaborators
Hyuk moon Kim
Dong-A Pharmaceutical Co., Ltd.
Investigators
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Study Chair: Chul Wan Lim, MD,PhD Soonchunhyang U Puchun Hospital
More Information
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Publications of Results:

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Responsible Party: Hyuk moon Kim, Assistant professor, Sunchonhang University
ClinicalTrials.gov Identifier: NCT01571518    
Other Study ID Numbers: 2011-91
First Posted: April 5, 2012    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012
Keywords provided by Hyuk moon Kim, Sunchonhang University:
G-CSF
neutropenia
TAC
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases