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

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

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

Sponsors & Collaborators

• Beijing Hospital

  collaborator OTHER_GOV

• China-Japan Friendship Hospital

  collaborator OTHER

• Navy General Hospital, Beijing

  collaborator OTHER

• Seventh Medical Center of PLA Army General Hospital

  collaborator OTHER

• Lei Li

  lead OTHER

Principal Investigators

• Lei Li, M.D. · Peking Union Medical College Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-01

Primary Completion

2020-10-01

Completion

2020-10-01

Countries

• China

Study Locations