Chemotherapy-induced Neutropenia, Colony Stimulating Factors Adverse Reaction, Cost-effectiveness Analysis, Epithelial Ovarian Cancer, Febrile Neutropenia, Drug-Induced, Granulocyte Colony Stimulating Factor, Overall Survival, Progression-free Survival, Quality of Life
Conditions
Brief summary
This study aims to analyze the effects of long-acting versus short-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer patients. Patients receive platinum-based chemotherapy of 3 to 4 weeks. 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 or prophylactic treatment of short-acting G-CSF according to National Comprehensive Cancer Network guidelines. 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, quality of life, and survival outcomes (progression-free survival and overall survival).
Interventions
Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy
DRUGShort-acting granulocyte colony stimulating factor
Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns
Sponsors
Beijing Hospital
China-Japan Friendship Hospital
Navy General Hospital, Beijing
Seventh Medical Center of PLA Army General Hospital
Lei Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* With definitive pathological results of epithelial ovarian cancer * With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 * Aged 18 or older * Receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery * Regularly followed up in the study centers * Provided consent for participation.
Exclusion criteria
* Failure to meet all the inclusion criteria * Non-compliance with the study protocols * With a history of chemotherapy or pelvic radiotherapy for malignancies * Presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome * Treated with weekly chemotherapy regimens * Presence of hematological disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of febrile neutropenia | One year | Incidence of febrile neutropenia during each course of chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Doses of granulocyte colony stimulating factor | One year | Doses of long-acting and short-acting granulocyte colony stimulating factor used during each course of chemotherapy |
| Numbers of visits to the hospital | One year | Visits to the outpatient clinics and emergency room |
| Incidence of myelosuppression | One year | Incidence of febrile neutropenia during each course of chemotherapy |
| Progression-free survival | Two years | Progression-free survival after the treatment of ovarian cancer during the study periods |
| Overall survival | Two years | Overall survival after the treatment of ovarian cancer during the study periods |
| Adverse events | One years | Incidence of adverse events related to granulocyte colony stimulating factor according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03 |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Backup ContactMing Wu, M.D.
Outcome results
None listed