Long-acting G-CSF for Febrile Neutropenia

November 9, 2018 updated by: Lei Li

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

556

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Study group
Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression.
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
Other Names:
  • polyethylene glycol granulocyte colony stimulating factor
Drug: Short-term granulocyte colony stimulating factor
Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression
ACTIVE_COMPARATOR: Control group
Patients in control group only accept regular interventions for myelosuppression rather than long-acting granulocyte colony stimulating factor.
Drug: Short-term granulocyte colony stimulating factor
Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
febrile neutropenia
Time Frame: One year
the incidence of febrile neutropenia happened during each course of chemotherapy
One year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lei Li

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 10, 2018

Primary Completion (ANTICIPATED)

November 10, 2019

Study Completion (ANTICIPATED)

November 10, 2023

Study Registration Dates

First Submitted

November 9, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (ACTUAL)

November 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 9, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOC-GCSF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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