Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Sunchonhang University.
Recruitment status was  Not yet recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014