Prevention of Neutropenia After Using G-CSF With TAC Chemotherapy

NCT ID: NCT01571518

Last Updated: 2012-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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

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Neutropenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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early injection

injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy

Group Type EXPERIMENTAL

late leukostim

Intervention Type DRUG

injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy

late injection

injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy

Group Type SHAM_COMPARATOR

early leukostim

Intervention Type DRUG

injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy

Interventions

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late leukostim

injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy

Intervention Type DRUG

early leukostim

injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy

Intervention Type DRUG

Other Intervention Names

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5leuko 2leuko

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dong-A Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Hyuk moon Kim

OTHER

Sponsor Role lead

Responsible Party

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Hyuk moon Kim

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chul Wan Lim, MD,PhD

Role: STUDY_CHAIR

Soonchunhyang U Puchun Hospital

Locations

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Soonchunhyang university Puchun Hospital

Puchun, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Chul Wan Lim, M.D., Ph.D

Role: CONTACT

82-32-621-5114

Facility Contacts

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Hyuk moon Kim, MD

Role: primary

82-32-621-5114

References

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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.

Reference Type RESULT
PMID: 20232087 (View on PubMed)

Other Identifiers

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2011-91

Identifier Type: -

Identifier Source: org_study_id

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