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

NCT03793205 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Gynecologic Cancer
  • Myelosuppression Adult
  • Febrile Neutropenia
  • Chemotherapy-induced Neutropenia

Interventions

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.

DRUG

Short-acting G-CSF

Short-acting G-CSF will be given as required 24 hours after the chemotherapy.

Sponsors & Collaborators

  • Lei Li

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-03
Primary Completion
2020-01-01
Completion
2020-01-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03793205 on ClinicalTrials.gov