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Long-acting G-CSF for Febrile Neutropenia

NCT03740464 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 556

Last updated 2018-11-14

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 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.

Conditions

  • Epithelial Ovarian Cancer
  • Colony Stimulating Factors
  • Febrile Neutropenia
  • Myelosuppression Adult
  • Adverse Event
  • Cost-effectiveness

Interventions

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

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

Sponsors & Collaborators

  • Lei Li

    lead OTHER

Principal Investigators

  • Lei Li, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-10
Primary Completion
2019-11-10
Completion
2023-11-10

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 NCT03740464 on ClinicalTrials.gov