NeutropeniaPhase 4NCT01571518
Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy
A Phase 4 study testing late leukostim and early leukostim in people with Neutropenia, run by Hyuk moon Kim at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Neutropenia
- What is being tested?
- late leukostim and early leukostim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Oct 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary invasive breast carcinoma with lymph node positive with curative surgery with TAC chemotherapy
Who cannot join
- pregnancy,
- cardiovascualr disease,
- abnormal renal function,
- hematologic disorder
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soonchunhyang university Puchun Hospital
Puchun
Hyuk moon Kim, MD, 82-32-621-5114, hmkim@soonchunhyang.com
ChulWan Lim, MD.PhD
About this study
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
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.
Read the 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.
- Conditions
- Neutropenia
- Being tested
- late leukostim, early leukostim
- Keywords
- G-CSF, neutropenia, TAC
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
late leukostimDrug
Also called 5leuko
injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy
early leukostimDrug
Also called 2leuko
injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| early injection | Experimental | injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy Receives: Drug: late leukostim |
| late injection | Sham comparator | injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy Receives: Drug: early leukostim |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of neutropenia
during the 1 cycle (21days) of ajuvant chemotherapy with TAC, record the frequency of neutropenia aftr using G-CSF (Leucostim)
Measured: Change from Baseline in neutrophil count at 21days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyuk moon Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Hyuk moon Kim, Sunchonhang University
- Investigators
- Chul Wan Lim, MD,PhD, Study chair, Soonchunhyang U Puchun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571518
- Sponsor's protocol ID
- 2011-91
- Status last verified
- Apr 2012
- First submitted
- 29 Mar 2012
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20232087
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01571518
- Acronym / sponsor ID
- 2011-91
- Conditions
- Neutropenia
- Keywords
- G-CSF, neutropenia, TAC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hyuk moon KimUniversity, hospital or other
- Collaborators
- Dong-A Pharmaceutical Co., Ltd.
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early injection | Experimental | Drug: late leukostiminjection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy |
| late injection | Sham comparator | Drug: early leukostiminjection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary invasive breast carcinoma with lymph node positive with curative surgery with TAC chemotherapy
Key exclusion criteria (4 listed)
- pregnancy,
- cardiovascualr disease,
- abnormal renal function,
- hematologic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| late leukostimAlso: 5leukoinjection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy | Drug | early injection |
| early leukostimAlso: 2leukoinjection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy | Drug | late injection |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
- Results publication: PubMed 20232087Chan 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.
Related trials for Neutropenia
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
Diffuse Large B Cell Lymphoma, Multiple Myeloma
RecruitingPhase 4
Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance
Febrile Neutropenia
Not yet recruitingPhase 2
A Study to Investigate the Safety and Tolerability of Granulocyte-colony Stimulating Factor (G-CSF) Dosage Reduction in Mavorixafor-treated Participants With Acquired Primary Autoimmune and Idiopathic Chronic Neutropenia Disorders
Acquired Primary Autoimmune and Idiopathic Chronic Neutropenia Disorders, Chronic Neutropenia
Not yet recruiting
Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
Suspected Neutropenic Fever, Confirmed Neutropenic Fever
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chul Wan Lim, MD,PhD study chair
Soonchunhyang U Puchun Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing late leukostim and early leukostim in people with Neutropenia, run by Hyuk moon Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chul Wan Lim, M.D., Ph.D (82-32-621-5114, cylim@soonchunhyang.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of neutropenia (time frame: Change from Baseline in neutrophil count at 21days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2012.