This study is to examine which dose of DA-3031(PEG-G-CSF) has similar efficacy and safety compared to daily G-CSF in chemotherapy-induced neutropenia.
Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily G-CSF(up to 10 days). This study is conducted for 1 cycles of chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Korea University GURO hospital
Seoul, South Korea
Duration of grade 4 neutropenia in cycle 1
Grade 4 neutropenia means the ANC count is less than 500/mm3.
Time frame: 21 day
ANC nadir in cycle 1
ANC nadir means the lowest point of ANC count.
Time frame: 21 day
Time to ANC recovery in cycle 1
ANC recovery means the ANC count is more than 2,000/mm3.
Time frame: 21 day
Incidence of febrile neutropenia in cycle 1
Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius.
Time frame: 21 day
Incidence of IV antibiotics administration in cycle 1
IV antibiotics administration means that antibiotics are administered through intravenous route.
Time frame: 21 day
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