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

Lei Li

Status and phase: Unknown; Phase 4

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

Treatments: Drug: Long-acting G-CSF; Drug: Short-acting G-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT03793205

GO-GCSF

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Long-acting G-CSF group

Experimental group

Description:

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

Treatment:

Drug: Long-acting G-CSF

Short-acting G-CSF group

Experimental group

Description:

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

Treatment:

Drug: Short-acting G-CSF