G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients

January 3, 2019 updated by: Lei Li

Long-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients: A Prospective Cohort Study

This study aims to analyze the effects of long-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in gynecologic cancer patients. Patients all accepted platinum-based chemotherapy 3-4 weeks once per course. The primary end is the incidence of FN in every course of chemotherapy. After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF. 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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

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:

  • Confirmed primary gynecologic cancer
  • 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: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long-acting G-CSF group
Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF.
Drug: Long-acting G-CSF
Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.
Experimental: Short-acting G-CSF group
Patients in long-acting G-CSF group only accept short-acting G-CSF.
Drug: Short-acting G-CSF
Short-acting G-CSF will be given as required 24 hours after the chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of febrile neutropenia
Time Frame: One year
Incidence of febrile neutropenia in each course
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidences of grade 3/4 myelosuppression
Time Frame: One year
Incidences of grade 3/4 myelosuppression in each course
One year
Times of visits to outpatient and emergency clinics
Time Frame: One year
Visits to outpatient and emergency clinics in each course
One year
Doses of G-CSF
Time Frame: One year
Doses of G-CSF administrated in each course
One year

Collaborators and Investigators

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

Sponsor

Lei Li

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)

January 3, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

January 3, 2019

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO-GCSF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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