An observational study in Febrile Neutropenia, sponsored by Zhejiang Cancer Hospital. Status unknown. Open to female participants aged 13 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-12-27.
Sponsored by Zhejiang Cancer Hospital · Observational
This clinical study is a multiple center, registering and real-world conditional research. The breast cancer patients planning for chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF in at least two cycles of chemotherapy according to real-world clinical judgement and choice by physicians in local cancer center. Comparing real conditional-FN rate, FN-caused hospitalization rate and antibiotic use rate, direct/indirect medical cost.
The breast cancer patients planning for neo-adjuvant/adjuvant chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) according to NCCN and ASCO guideline are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF according to real-world clinical judgement and choice by physicians in local cancer center for at least two cycles of chemotherapy. The primary outcome is FN rate, the second outcomes are rate of 3-4 grade decrease of ANC, FN-caused hospitalization, FN-caused antibiotic use rate, rate of reduction of chemotherapy dose, delay of chemotherapy, safety and pharmacoeconomics.
396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 175 across 96 observational studies indexed under Neutropenia.
Browse Neutropenia studies →Zhejiang Cancer Hospital is the lead sponsor of 271 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who undergoing chemotherapy given by prophylactic PEG-rhG-CSF using for preventing FN.
Exclusion Criteria:
The first level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in all cycles of chemotherapy.
Drug: PEGCSF first level prophylactic use
The second level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in the next cycle until FN or 4 grade neutropenia happened.
Drug: PEGCSF second level prophylactic use
6mg (≥45kg) or 3mg (\<45kg) i.h. once 24h after chemotherapy in all cycles of chemotherapy
Also known as: Xin Rui Bai
6mg (≥45kg) or 3mg (\<45kg) i.h. once 24h after chemotherapy in next cycle if FN or 4 grade neutropenia happened
Also known as: Xin Rui Bai
FN rate
rate of febrile neutropenia during all cycles of chemotherapy
Time frame: assessment at 1 month after the last cycle chemotherapy complete
rate of 3-4 grade neutropenia
rate of 3-4 grade decrease of ANC
Time frame: During all cycles of chemotherapy, through study completion, an average of half year
FN-caused hospitalization
rate of FN-caused hospitalization
Time frame: During all cycles of chemotherapy, through study completion, an average of half year
FN-caused antibiotic use rate
rate of FN-caused antibiotic use
Time frame: During all cycles of chemotherapy, through study completion, an average of half year
rate of dose reduction
rate of reduction of chemotherapy dose
Time frame: During all cycles of chemotherapy, through study completion, an average of half year
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Zhejiang Cancer Hospital