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Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer

Primary Purpose

Chemotherapy-induced Neutropenia, Febrile Neutropenia, Drug-Induced, Epithelial Ovarian Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Long-acting granulocyte colony stimulating factor
Short-acting 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 Chemotherapy-induced Neutropenia

Eligibility Criteria

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

Inclusion Criteria:

  • With definitive pathological results of epithelial ovarian cancer
  • With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2
  • Aged 18 or older
  • Receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery
  • Regularly followed up in the study centers
  • Provided consent for participation.

Exclusion Criteria:

  • Failure to meet all the inclusion criteria
  • Non-compliance with the study protocols
  • With a history of chemotherapy or pelvic radiotherapy for malignancies
  • Presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome
  • Treated with weekly chemotherapy regimens
  • Presence of hematological disorders

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 prophylactic treatment of long-acting granulocyte colony stimulating factor

Patients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines

Outcomes

Primary Outcome Measures

Incidence of febrile neutropenia
Incidence of febrile neutropenia during each course of chemotherapy

Secondary Outcome Measures

Incidence of myelosuppression
Incidence of febrile neutropenia during each course of chemotherapy
Doses of granulocyte colony stimulating factor
Doses of long-acting and short-acting granulocyte colony stimulating factor used during each course of chemotherapy
Numbers of visits to the hospital
Visits to the outpatient clinics and emergency room
Adverse events
Incidence of adverse events related to granulocyte colony stimulating factor according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Progression-free survival
Progression-free survival after the treatment of ovarian cancer during the study periods
Overall survival
Overall survival after the treatment of ovarian cancer during the study periods

Full Information

First Posted
September 21, 2019
Last Updated
October 5, 2019
Sponsor
Lei Li
Collaborators
Beijing Hospital, China-Japan Friendship Hospital, Navy General Hospital, Beijing, Seventh Medical Center of PLA Army General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04101760
Brief Title
Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer
Official Title
Long-acting Versus Short-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer Patients: A Multicenter Phase 3 Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Li
Collaborators
Beijing Hospital, China-Japan Friendship Hospital, Navy General Hospital, Beijing, Seventh Medical Center of PLA Army General Hospital

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 versus short-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer patients. Patients receive platinum-based chemotherapy of 3 to 4 weeks. 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 or prophylactic treatment of short-acting G-CSF according to National Comprehensive Cancer Network guidelines. 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, quality of life, and survival outcomes (progression-free survival and overall survival).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Neutropenia, Febrile Neutropenia, Drug-Induced, Epithelial Ovarian Cancer, Colony Stimulating Factors Adverse Reaction, Granulocyte Colony Stimulating Factor, Cost-effectiveness Analysis, Quality of Life, Progression-free Survival, Overall Survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines
Intervention Type
Drug
Intervention Name(s)
Long-acting granulocyte colony stimulating factor
Intervention Description
Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy
Intervention Type
Drug
Intervention Name(s)
Short-acting granulocyte colony stimulating factor
Intervention Description
Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns
Primary Outcome Measure Information:
Title
Incidence of febrile neutropenia
Description
Incidence of febrile neutropenia during each course of chemotherapy
Time Frame
One year
Secondary Outcome Measure Information:
Title
Incidence of myelosuppression
Description
Incidence of febrile neutropenia during each course of chemotherapy
Time Frame
One year
Title
Doses of granulocyte colony stimulating factor
Description
Doses of long-acting and short-acting granulocyte colony stimulating factor used during each course of chemotherapy
Time Frame
One year
Title
Numbers of visits to the hospital
Description
Visits to the outpatient clinics and emergency room
Time Frame
One year
Title
Adverse events
Description
Incidence of adverse events related to granulocyte colony stimulating factor according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Time Frame
One years
Title
Progression-free survival
Description
Progression-free survival after the treatment of ovarian cancer during the study periods
Time Frame
Two years
Title
Overall survival
Description
Overall survival after the treatment of ovarian cancer during the study periods
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: With definitive pathological results of epithelial ovarian cancer With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 Aged 18 or older Receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery Regularly followed up in the study centers Provided consent for participation. Exclusion Criteria: Failure to meet all the inclusion criteria Non-compliance with the study protocols With a history of chemotherapy or pelvic radiotherapy for malignancies Presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome Treated with weekly chemotherapy regimens Presence of hematological disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Li, M.D.
Phone
+8613911988831
Email
lileigh@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Wu, M.D.
Phone
+8613801224549
Email
wuming@pumch.cn
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

Plan to Share IPD
Yes
IPD Sharing Plan Description
The individual participant data will be shared as a supplement along with the published papers.

Learn more about this trial

Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer

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