Long-acting G-CSF for Febrile Neutropenia

Phase 3

• Conditions: Myelosuppression Adult; Adverse Event; Cost-effectiveness; Colony Stimulating Factors; Epithelial Ovarian Cancer; Febrile Neutropenia
• Interventions: Drug: long-acting granulocyte colony stimulating factor; Drug: Short-term granulocyte colony stimulating factor

• Registration Number: NCT03740464
• Lead Sponsor: Lei Li

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2018-11-09
• Last Update Submitted: 2018-11-09
• Study Start: 2018-11-10
• Study First Posted: 2018-11-14
• Last Update Posted: 2018-11-14
• Primary Completion: 2019-11-10
• Study Completion: 2023-11-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 556

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	long-acting granulocyte colony stimulating factor	Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression.
Study group	Short-term granulocyte colony stimulating factor	Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression.
Control group	Short-term granulocyte colony stimulating factor	Patients in control group only accept regular interventions for myelosuppression rather than long-acting granulocyte colony stimulating factor.

Primary Outcome Measures

Name	Time	Method
febrile neutropenia	One year	the incidence of febrile neutropenia happened during each course of chemotherapy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China