Long-acting G-CSF for Febrile Neutropenia

Epithelial Ovarian Cancer Clinical Trial

Official title:

Long-acting Granulocyte Colony Stimulating Factor for the Prevention Febrile Neutropenia in Epithelial Ovarian Cancer: A Phase 3 Randomized Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03740464
• Other study ID #: EOC-GCSF
• Status: Recruiting
• Phase: Phase 3
• Start date: November 10, 2018
• Est. completion date: November 10, 2023

Study information

• Verified date: November 2018
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D.
• Phone: 13911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 556
• Est. completion date: November 10, 2023
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Event
• Colony Stimulating Factors
• Cost-effectiveness
• Epithelial Ovarian Cancer
• Febrile Neutropenia
• Fever
• Myelosuppression Adult
• Neoplasms, Glandular and Epithelial
• Neutropenia
• Ovarian Neoplasms

Intervention

Drug:
• long-acting granulocyte colony stimulating factor
A 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group
• Short-term granulocyte colony stimulating factor
Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	febrile neutropenia	the incidence of febrile neutropenia happened during each course of chemotherapy	One year
Secondary	myelosuppression	the incidence of the incidence of febrile neutropenia happened during each course of chemotherapy happened during each course of chemotherapy	One year
Secondary	doses of granulocyte colony stimulating factor	total doses of all granulocyte colony stimulating factor	One year
Secondary	expenses of granulocyte colony stimulating factor	total expenses of all granulocyte colony stimulating factor	One year
Secondary	visits to the hospital	visits to outpatient and emergency clinics	One years
Secondary	adverse events	adverse events related to G-CSF according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03	One year
Secondary	progression-free survival	progression-free survival after the primary treatment of ovarian cancer	Five years