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

Gynecologic Cancer Clinical Trial

Official title:

Long-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03793205
• Other study ID #: GO-GCSF
• Status: Recruiting
• Phase: Phase 4
• Start date: January 3, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2019
• Source: Peking Union Medical College Hospital
• Contact: Lei Li
• Phone: +8613911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Neutropenia
• Febrile Neutropenia
• Fever
• Gynecologic Cancer
• Myelosuppression Adult
• Neutropenia

Intervention

Drug:
• Long-acting G-CSF
Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.
• Short-acting G-CSF
Short-acting G-CSF will be given as required 24 hours after the chemotherapy.

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of febrile neutropenia	Incidence of febrile neutropenia in each course	One year
Secondary	Incidences of grade 3/4 myelosuppression	Incidences of grade 3/4 myelosuppression in each course	One year
Secondary	Times of visits to outpatient and emergency clinics	Visits to outpatient and emergency clinics in each course	One year
Secondary	Doses of G-CSF	Doses of G-CSF administrated in each course	One year