Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy
Primary Purpose
Neutropenia
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
late leukostim
early leukostim
Sponsored by
About this trial
This is an interventional prevention trial for Neutropenia focused on measuring G-CSF, neutropenia, TAC
Eligibility 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
Sites / Locations
- Soonchunhyang university Puchun Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
early injection
late injection
Arm Description
injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy
injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy
Outcomes
Primary Outcome Measures
frequency of neutropenia
during the 1 cycle (21days) of ajuvant chemotherapy with TAC, record the frequency of neutropenia aftr using G-CSF (Leucostim)
Secondary Outcome Measures
Full Information
NCT ID
NCT01571518
First Posted
March 29, 2012
Last Updated
April 3, 2012
Sponsor
Hyuk moon Kim
Collaborators
Dong-A Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01571518
Brief Title
Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hyuk moon Kim
Collaborators
Dong-A Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia
Keywords
G-CSF, neutropenia, TAC
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
early injection
Arm Type
Experimental
Arm Description
injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy
Arm Title
late injection
Arm Type
Sham Comparator
Arm Description
injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy
Intervention Type
Drug
Intervention Name(s)
late leukostim
Other Intervention Name(s)
5leuko
Intervention Description
injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy
Intervention Type
Drug
Intervention Name(s)
early leukostim
Other Intervention Name(s)
2leuko
Intervention Description
injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy
Primary Outcome Measure Information:
Title
frequency of neutropenia
Description
during the 1 cycle (21days) of ajuvant chemotherapy with TAC, record the frequency of neutropenia aftr using G-CSF (Leucostim)
Time Frame
Change from Baseline in neutrophil count at 21days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chul Wan Lim, M.D., Ph.D
Phone
82-32-621-5114
Email
cylim@soonchunhyang.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chul Wan Lim, MD,PhD
Organizational Affiliation
Soonchunhyang U Puchun Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Soonchunhyang university Puchun Hospital
City
Puchun
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyuk moon Kim, MD
Phone
82-32-621-5114
Email
hmkim@soonchunhyang.com
First Name & Middle Initial & Last Name & Degree
ChulWan Lim, MD.PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
20232087
Citation
Chan A, Fu WH, Shih V, Coyuco JC, Tan SH, Ng R. Impact of colony-stimulating factors to reduce febrile neutropenic events in breast cancer patients receiving docetaxel plus cyclophosphamide chemotherapy. Support Care Cancer. 2011 Apr;19(4):497-504. doi: 10.1007/s00520-010-0843-8. Epub 2010 Mar 17.
Results Reference
result
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Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy
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