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Long-acting Versus Short-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer Patients: A Multicenter Phase 3 Randomized Controlled Study
This study aims to analyze the effects of long-acting versus short-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer patients. Patients receive platinum-based chemotherapy of 3 to 4 weeks. Patients are randomized into study group and control group. In study group, patients accept long-acting G-CSF 48 hours from the chemotherapy. While the control group accept regular or prophylactic treatment of short-acting G-CSF according to National Comprehensive Cancer Network guidelines. The primary end is the incidence of FN in every course of chemotherapy. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF, quality of life, and survival outcomes (progression-free survival and overall survival).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Lei Li
Beijing, Beijing Municipality, China
Start Date
October 1, 2019
Primary Completion Date
October 1, 2020
Completion Date
October 1, 2020
Last Updated
October 8, 2019
200
ESTIMATED participants
Long-acting granulocyte colony stimulating factor
DRUG
Short-acting granulocyte colony stimulating factor
DRUG
Lead Sponsor
Lei Li
Collaborators
NCT07432633
NCT05867251
Data Source & Attribution
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