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Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy

This study is not yet open for participant recruitment.
Verified April 2012 by Sunchonhang University
Sponsor:
Collaborator:
Dong-A Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Hyuk moon Kim, Sunchonhang University
ClinicalTrials.gov Identifier:
NCT01571518
First received: March 29, 2012
Last updated: April 3, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Neutropenia
 Drug: late leukostim
Drug: early leukostim
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Sunchonhang University:

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


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571518

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

Locations
Korea, Republic of
Soonchunhyang university Puchun Hospital Not yet recruiting
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
Study Chair: Chul Wan Lim, MD,PhD Soonchunhyang U Puchun Hospital
  More Information

Publications:

Responsible Party: Hyuk moon Kim, Assistant professor, Sunchonhang University
ClinicalTrials.gov Identifier: NCT01571518     History of Changes
Other Study ID Numbers: 2011-91
Study First Received: March 29, 2012
Last Updated: April 3, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Sunchonhang University:
G-CSF
neutropenia
TAC

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013