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Efficacy and Safety of PEG-rhG-CSF Secondary Prophylaxis vs. Therapeutic Administration in Patients With Ovarian Cancer

Shandong University · 2017
ClinicalTrials.gov · Datasets · License: Public Domain · 2017
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ovarian-cancer
This study is a multicenter, open-label, randomized clinical trial. Patients with ovarian cancer receiving postoperative adjuvant chemotherapy were eligible to enroll in this study. Eligible patients were randomly allocated in a "1:1" to "Standard group" ( 6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy) and "Adjusted group" (6mg PEG-rhG-CSF was administrated subcutaneously when ANC \< 1000/mm3 after chemotherapy). All patients need to receive at least 2 cycles of PEG-rhG-CSF administration. The primary outcome is the incidence of grade 3/4 neutropenia, and the duration of grade 3/4 neutropenia, the second outcomes are the incidence of FN, neutropenia-related hospitalization, incidence of reduction and delay of chemotherapy dose and safety of PEG-rhG-CSF.
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