NCT04101760

Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Chemotherapy-induced Neutropenia
• Febrile Neutropenia, Drug-Induced
• Epithelial Ovarian Cancer
• Colony Stimulating Factors Adverse Reaction
• Granulocyte Colony Stimulating Factor
• Cost-effectiveness Analysis
• Quality of Life
• Progression-free Survival
• Overall Survival

Interventions

Type	Name	Description
DRUG	Long-acting granulocyte colony stimulating factor	Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy
DRUG	Short-acting granulocyte colony stimulating factor	Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2019-09-24
• Last updated: 2019-10-08

Locations

1 site across 1 country: China