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

Lei Li

Status and phase: Unknown; Phase 3

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

Treatments: Drug: Short-acting granulocyte colony stimulating factor; Drug: Long-acting granulocyte colony stimulating factor

Study type: Interventional

Funder types: Other

Identifiers

NCT04101760

EOC-CSF

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With definitive pathological results of epithelial ovarian cancer
• With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
• Aged 18 or older
• Receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery
• Regularly followed up in the study centers
• Provided consent for participation.

Exclusion criteria

• Failure to meet all the inclusion criteria
• Non-compliance with the study protocols
• With a history of chemotherapy or pelvic radiotherapy for malignancies
• Presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome
• Treated with weekly chemotherapy regimens
• Presence of hematological disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Study group

Experimental group

Description:

Patients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor

Treatment:

Drug: Long-acting granulocyte colony stimulating factor

Control group

Active Comparator group

Description:

Patients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines

Treatment:

Drug: Short-acting granulocyte colony stimulating factor