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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
Lei Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
November 9, 2018
Last Updated
November 9, 2018
Sponsor
Lei Li
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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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