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

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

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).

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Epithelial Ovarian Cancer; Chemotherapy-induced Neutropenia; Overall Survival; Progression-free Survival; Febrile Neutropenia, Drug-Induced; Colony Stimulating Factors Adverse Reaction; Granulocyte Colony Stimulating Factor; Cost-effectiveness Analysis
• Intervention / Treatment: Drug: Long-acting granulocyte colony stimulating factor; Drug: Short-acting granulocyte colony stimulating factor

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Lei Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study group; Patients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor	Drug: Long-acting granulocyte colony stimulating factor; Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy
ACTIVE_COMPARATOR: Control group; Patients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines	Drug: Short-acting granulocyte colony stimulating factor; Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of febrile neutropenia	Incidence of febrile neutropenia during each course of chemotherapy	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of myelosuppression	Incidence of febrile neutropenia during each course of chemotherapy	One year
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
Numbers of visits to the hospital	Visits to the outpatient clinics and emergency room	One year
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
Progression-free survival	Progression-free survival after the treatment of ovarian cancer during the study periods	Two years
Overall survival	Overall survival after the treatment of ovarian cancer during the study periods	Two years

Collaborators and Investigators

• Sponsor: Lei Li
• Collaborators: Beijing Hospital; China-Japan Friendship Hospital; Navy General Hospital, Beijing; Seventh Medical Center of PLA Army General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2019
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): October 1, 2020

Study Registration Dates

• First Submitted: September 21, 2019
• First Submitted That Met QC Criteria: September 21, 2019
• First Posted (ACTUAL): September 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 5, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Wounds and Injuries; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Hematologic Diseases; Endocrine Gland Neoplasms; Agranulocytosis; Leukopenia; Leukocyte Disorders; Body Temperature Changes; Heat Stress Disorders; Ovarian Neoplasms; Neutropenia; Carcinoma, Ovarian Epithelial; Hyperthermia; Fever; Febrile Neutropenia; Chemotherapy-Induced Febrile Neutropenia; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: EOC-CSF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data will be shared as a supplement along with the published papers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No