G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients

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 gynecologic cancer patients. Patients all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF. 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 of Febrile Neutropenia in Gynecologic Cancer Patients: A Prospective Cohort Study

Conditions
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Gynecologic Cancer, Myelosuppression Adult, Febrile Neutropenia, Chemotherapy-induced Neutropenia

Intervention / Treatment
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* Drug: Long-acting G-CSF
* Drug: Short-acting G-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed primary gynecologic cancer 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: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long-acting G-CSF group<br>Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF. | Drug: Long-acting G-CSF<br>* Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.<br>|
| Experimental: Short-acting G-CSF group<br>Patients in long-acting G-CSF group only accept short-acting G-CSF. | Drug: Short-acting G-CSF<br>* Short-acting G-CSF will be given as required 24 hours after the chemotherapy.<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 in each course | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of grade 3/4 myelosuppression | Incidences of grade 3/4 myelosuppression in each course | One year | 
| Times of visits to outpatient and emergency clinics | Visits to outpatient and emergency clinics in each course | One year | 
| Doses of G-CSF | Doses of G-CSF administrated in each course | One year |