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

NCT03793205 | Unknown Phase 4

• 1 other identifier: GO-GCSF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of febrile neutropenia

  Incidence of febrile neutropenia in each course

  One year

Secondary Outcomes (3)

• Incidences of grade 3/4 myelosuppression

  One year

• Times of visits to outpatient and emergency clinics

  One year

• Doses of G-CSF

  One year

Study Arms (2)

Long-acting G-CSF group

EXPERIMENTAL

Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF.

Drug: Long-acting G-CSF

Short-acting G-CSF group

EXPERIMENTAL

Patients in long-acting G-CSF group only accept short-acting G-CSF.

Drug: Short-acting G-CSF

Interventions

Long-acting G-CSF DRUG

Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.

Long-acting G-CSF group

Short-acting G-CSF DRUG

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

Short-acting G-CSF group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed primary gynecologic cancer
• Good performance status
• Aged 18 years or older
• Signed an approved informed consents
• No immunosuppressive disease

Sponsors & Collaborators

• Lei Li: lead

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• Chen X, Wu M, Ma S, Tan X, Zhong S, Li L. Effects of long-acting versus short-acting granulocyte colony stimulating factor after radiotherapy in gynecologic malignancies: a prospective observational cohort study. BMC Cancer. 2024 Dec 18;24(1):1512. doi: 10.1186/s12885-024-13296-1.

  PMID: 39696092 DERIVED

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Central Study Contacts

Lei Li

CONTACT

+8613911988831; lileigh@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 4, 2019
• Study Start: January 3, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 7, 2019

Record last verified: 2019-01

Locations

CN (1)