NCT03740464

Long-acting G-CSF for Febrile Neutropenia

Long-acting Granulocyte Colony Stimulating Factor for the Prevention Febrile Neutropenia in Epithelial Ovarian Cancer: A Phase 3 Randomized Control Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 556 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer. 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 treatment rather than long-acting G-CSF. 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.

Conditions

• Epithelial Ovarian Cancer
• Colony Stimulating Factors
• Febrile Neutropenia
• Myelosuppression Adult
• Adverse Event
• Cost-effectiveness

Interventions

Type	Name	Description
DRUG	long-acting granulocyte colony stimulating factor	A 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group
DRUG	Short-term granulocyte colony stimulating factor	Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression

Timeline

• Start date: 2018-11-10
• Primary completion: 2019-11-10
• Completion: 2023-11-10
• First posted: 2018-11-14
• Last updated: 2018-11-14

Locations

1 site across 1 country: China