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

Phase 4

• Conditions: Gynecologic Cancer; Myelosuppression Adult; Febrile Neutropenia; Chemotherapy-induced Neutropenia
• Interventions: Drug: Short-acting G-CSF; Drug: Long-acting G-CSF

• Registration Number: NCT03793205
• Lead Sponsor: Lei Li

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-03
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Last Update Submitted: 2019-01-03
• Study First Posted: 2019-01-04
• Last Update Posted: 2019-01-07
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Short-acting G-CSF group	Short-acting G-CSF	Patients in long-acting G-CSF group only accept short-acting G-CSF.
Long-acting G-CSF group	Long-acting G-CSF	Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF.

Primary Outcome Measures

Name	Time	Method
Incidence of febrile neutropenia	One year	Incidence of febrile neutropenia in each course

Secondary Outcome Measures

Name	Time	Method
Incidences of grade 3/4 myelosuppression	One year	Incidences of grade 3/4 myelosuppression in each course
Doses of G-CSF	One year	Doses of G-CSF administrated in each course
Times of visits to outpatient and emergency clinics	One year	Visits to outpatient and emergency clinics in each course

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China