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

Sponsor
Lei Li (Other)
Overall Status
Unknown status
CT.gov ID
NCT03793205
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
11.9
Anticipated Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Long-acting G-CSF
  • Drug: Short-acting G-CSF
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients: A Prospective Cohort Study
Actual Study Start Date :
Jan 3, 2019
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Jan 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of febrile neutropenia [One year]

    Incidence of febrile neutropenia in each course

Secondary Outcome Measures

  1. Incidences of grade 3/4 myelosuppression [One year]

    Incidences of grade 3/4 myelosuppression in each course

  2. Times of visits to outpatient and emergency clinics [One year]

    Visits to outpatient and emergency clinics in each course

  3. Doses of G-CSF [One year]

    Doses of G-CSF administrated in each course

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lei Li Beijing Beijing China 100730

Sponsors and Collaborators

  • Lei Li

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT03793205
Other Study ID Numbers:
  • GO-GCSF
First Posted:
Jan 4, 2019
Last Update Posted:
Jan 7, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neutropenia
Febrile Neutropenia
Hyperthermia
Fever
Lenograstim

Study Results

No Results Posted as of Jan 7, 2019