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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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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

Intervention / Treatment
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* Drug: Long-acting granulocyte colony stimulating factor
* Drug: Short-acting granulocyte colony stimulating factor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor | Drug: Long-acting granulocyte colony stimulating factor<br>* Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy<br>|
| Active Comparator: Control group<br>Patients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines | Drug: Short-acting granulocyte colony stimulating factor<br>* Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of febrile neutropenia | Incidence of febrile neutropenia during each course of chemotherapy | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of myelosuppression | Incidence of febrile neutropenia during each course of chemotherapy | 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 | One year | 
| Numbers of visits to the hospital | Visits to the outpatient clinics and emergency room | 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 | One years | 
| Progression-free survival | Progression-free survival after the treatment of ovarian cancer during the study periods | Two years | 
| Overall survival | Overall survival after the treatment of ovarian cancer during the study periods | Two years |