Long-acting G-CSF for Febrile Neutropenia

Study Overview
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Brief Summary
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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.

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

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

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to accepted debulking surgeries and adjuvant chemotherapy Good performance status Aged 18 years or older Signed an approved informed consents No immunosuppressive disease Exclusion Criteria: Not meeting all of the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression. | Drug: long-acting granulocyte colony stimulating factor<br>* A 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group<br>* Other names: polyethylene glycol granulocyte colony stimulating factor;Drug: Short-term granulocyte colony stimulating factor<br>* Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression<br>|
| Active Comparator: Control group<br>Patients in control group only accept regular interventions for myelosuppression rather than long-acting granulocyte colony stimulating factor. | Drug: Short-term granulocyte colony stimulating factor<br>* Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myelosuppression | the incidence of the incidence of febrile neutropenia happened during each course of chemotherapy happened during each course of chemotherapy | One year | 
| doses of granulocyte colony stimulating factor | total doses of all granulocyte colony stimulating factor | One year | 
| expenses of granulocyte colony stimulating factor | total expenses of all granulocyte colony stimulating factor | One year | 
| visits to the hospital | visits to outpatient and emergency clinics | One years | 
| adverse events | adverse events related to G-CSF according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | One year | 
| progression-free survival | progression-free survival after the primary treatment of ovarian cancer | Five years |