Long-acting G-CSF for Febrile Neutropenia

Lei Li

Status and phase: Unknown; Phase 3

Conditions: Adverse Event; Febrile Neutropenia; Epithelial Ovarian Cancer; Colony Stimulating Factors; Myelosuppression Adult; Cost-effectiveness

Treatments: Drug: Short-term granulocyte colony stimulating factor; Drug: long-acting granulocyte colony stimulating factor

Study type: Interventional

Funder types: Other

Identifiers

NCT03740464

EOC-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 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.

Enrollment: 556 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to accepted debulking surgeries and adjuvant chemotherapy
• 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: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

556 participants in 2 patient groups

Study group

Experimental group

Description:

Patients in study group accept long-acting granulocyte colony stimulating factor 48 hours from the chemotherapy and regular interventions for myelosuppression.

Treatment:

Drug: Short-term granulocyte colony stimulating factor

Drug: long-acting granulocyte colony stimulating factor

Control group

Active Comparator group

Description:

Patients in control group only accept regular interventions for myelosuppression rather than long-acting granulocyte colony stimulating factor.

Treatment:

Drug: Short-term granulocyte colony stimulating factor