Back to resultsG-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients
Primary Purpose
Gynecologic Cancer, Myelosuppression Adult, Febrile Neutropenia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Long-acting G-CSF
Short-acting G-CSF
Sponsored by
About this trial
This is an interventional treatment trial for Gynecologic Cancer
Eligibility Criteria
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
Sites / Locations
- Lei LiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Long-acting G-CSF group
Short-acting G-CSF group
Arm Description
Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF.
Patients in long-acting G-CSF group only accept short-acting G-CSF.
Outcomes
Primary Outcome Measures
Incidence of febrile neutropenia
Incidence of febrile neutropenia in each course
Secondary Outcome Measures
Incidences of grade 3/4 myelosuppression
Incidences of grade 3/4 myelosuppression in each course
Times of visits to outpatient and emergency clinics
Visits to outpatient and emergency clinics in each course
Doses of G-CSF
Doses of G-CSF administrated in each course
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03793205
Brief Title
G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients
Official Title
Long-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients: A Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Li
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Myelosuppression Adult, Febrile Neutropenia, Chemotherapy-induced Neutropenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Long-acting G-CSF group
Arm Type
Experimental
Arm Description
Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF.
Arm Title
Short-acting G-CSF group
Arm Type
Experimental
Arm Description
Patients in long-acting G-CSF group only accept short-acting G-CSF.
Intervention Type
Drug
Intervention Name(s)
Long-acting G-CSF
Intervention Description
Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.
Intervention Type
Drug
Intervention Name(s)
Short-acting G-CSF
Intervention Description
Short-acting G-CSF will be given as required 24 hours after the chemotherapy.
Primary Outcome Measure Information:
Title
Incidence of febrile neutropenia
Description
Incidence of febrile neutropenia in each course
Time Frame
One year
Secondary Outcome Measure Information:
Title
Incidences of grade 3/4 myelosuppression
Description
Incidences of grade 3/4 myelosuppression in each course
Time Frame
One year
Title
Times of visits to outpatient and emergency clinics
Description
Visits to outpatient and emergency clinics in each course
Time Frame
One year
Title
Doses of G-CSF
Description
Doses of G-CSF administrated in each course
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Li
Phone
+8613911988831
Email
lileigh@163.com
Facility Information:
Facility Name
Lei Li
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Li, MD
Phone
008613911988831
Email
lileigh@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients
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