Long-acting G-CSF for Febrile Neutropenia
Primary Purpose
Epithelial Ovarian Cancer, Colony Stimulating Factors, Febrile Neutropenia
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
long-acting granulocyte colony stimulating factor
Short-term granulocyte colony stimulating factor
Sponsored by
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer
Eligibility Criteria
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
Sites / Locations
- Lei LiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study group
Control group
Arm Description
Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression.
Patients in control group only accept regular interventions for myelosuppression rather than long-acting granulocyte colony stimulating factor.
Outcomes
Primary Outcome Measures
febrile neutropenia
the incidence of febrile neutropenia happened during each course of chemotherapy
Secondary Outcome Measures
myelosuppression
the incidence of the incidence of febrile neutropenia happened during each course of chemotherapy happened during each course of chemotherapy
doses of granulocyte colony stimulating factor
total doses of all granulocyte colony stimulating factor
expenses of granulocyte colony stimulating factor
total expenses of all granulocyte colony stimulating factor
visits to the hospital
visits to outpatient and emergency clinics
adverse events
adverse events related to G-CSF according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
progression-free survival
progression-free survival after the primary treatment of ovarian cancer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03740464
Brief Title
Long-acting G-CSF for Febrile Neutropenia
Official Title
Long-acting Granulocyte Colony Stimulating Factor for the Prevention Febrile Neutropenia in Epithelial Ovarian Cancer: A Phase 3 Randomized Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2018 (Actual)
Primary Completion Date
November 10, 2019 (Anticipated)
Study Completion Date
November 10, 2023 (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
Yes
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Colony Stimulating Factors, Febrile Neutropenia, Myelosuppression Adult, Adverse Event, Cost-effectiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
556 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients in control group only accept regular interventions for myelosuppression rather than long-acting granulocyte colony stimulating factor.
Intervention Type
Drug
Intervention Name(s)
long-acting granulocyte colony stimulating factor
Other Intervention Name(s)
polyethylene glycol granulocyte colony stimulating factor
Intervention Description
A 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group
Intervention Type
Drug
Intervention Name(s)
Short-term granulocyte colony stimulating factor
Intervention Description
Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression
Primary Outcome Measure Information:
Title
febrile neutropenia
Description
the incidence of febrile neutropenia happened during each course of chemotherapy
Time Frame
One year
Secondary Outcome Measure Information:
Title
myelosuppression
Description
the incidence of the incidence of febrile neutropenia happened during each course of chemotherapy happened during each course of chemotherapy
Time Frame
One year
Title
doses of granulocyte colony stimulating factor
Description
total doses of all granulocyte colony stimulating factor
Time Frame
One year
Title
expenses of granulocyte colony stimulating factor
Description
total expenses of all granulocyte colony stimulating factor
Time Frame
One year
Title
visits to the hospital
Description
visits to outpatient and emergency clinics
Time Frame
One years
Title
adverse events
Description
adverse events related to G-CSF according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Time Frame
One year
Title
progression-free survival
Description
progression-free survival after the primary treatment of ovarian cancer
Time Frame
Five years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Li, M.D.
Phone
13911988831
Ext
86
Email
lileigh@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lei Li, M.D.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
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
Citations:
PubMed Identifier
31467066
Citation
Li L, Ma S, Wu M, Tan X, Zhong S, Lang J. The prophylactic effects of long-acting granulocyte colony-stimulating factor for febrile neutropenia in newly diagnosed patients with epithelial ovarian cancer: a randomised controlled study. BMJ Support Palliat Care. 2019 Dec;9(4):373-380. doi: 10.1136/bmjspcare-2019-001862. Epub 2019 Aug 29.
Results Reference
derived
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Long-acting G-CSF for Febrile Neutropenia
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