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

Lei Li200 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Chemotherapy-induced Neutropenia Febrile Neutropenia, Drug-Induced Epithelial Ovarian Cancer

Interventions

Long-acting granulocyte colony stimulating factorDRUG

Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy

Short-acting granulocyte colony stimulating factorDRUG

Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of febrile neutropenia

Incidence of febrile neutropenia during each course of chemotherapy

Time frame: One year

Secondary Outcomes

Incidence of myelosuppression

Incidence of febrile neutropenia during each course of chemotherapy

Time frame: One year

Doses of granulocyte colony stimulating factor

Doses of long-acting and short-acting granulocyte colony stimulating factor used during each course of chemotherapy

Time frame: One year

Numbers of visits to the hospital

Visits to the outpatient clinics and emergency room

Time frame: One year

Adverse events

Incidence of adverse events related to granulocyte colony stimulating factor according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Time frame: One years

Progression-free survival

Progression-free survival after the treatment of ovarian cancer during the study periods

Time frame: Two years

Overall survival

Overall survival after the treatment of ovarian cancer during the study periods

Time frame: Two years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts