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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04101760
• Other study ID #: EOC-CSF
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2019
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D.
• 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Chemotherapy-Induced Febrile Neutropenia
• Chemotherapy-induced Neutropenia
• Colony Stimulating Factors Adverse Reaction
• Cost-effectiveness Analysis
• Epithelial Ovarian Cancer
• Febrile Neutropenia
• Febrile Neutropenia, Drug-Induced
• Fever
• Granulocyte Colony Stimulating Factor
• Neutropenia
• Ovarian Neoplasms
• Overall Survival
• Progression-free Survival
• Quality of Life

Intervention

Drug:
• Long-acting granulocyte colony stimulating factor
Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy
• Short-acting granulocyte colony stimulating factor
Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Lei Li	Beijing Hospital, China-Japan Friendship Hospital, the Seventh Medical Center of PLA General Hospital, The Sixth Medical Center of PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

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