Adverse Event, Colony Stimulating Factors, Cost-effectiveness, Epithelial Ovarian Cancer, Febrile Neutropenia, Myelosuppression Adult
Conditions
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 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.
Interventions
A 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group
DRUGShort-term granulocyte colony stimulating factor
Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression
Sponsors
Lei Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| febrile neutropenia | One year | the incidence of febrile neutropenia happened during each course of chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| doses of granulocyte colony stimulating factor | One year | total doses of all granulocyte colony stimulating factor |
| expenses of granulocyte colony stimulating factor | One year | total expenses of all granulocyte colony stimulating factor |
| myelosuppression | One year | the incidence of the incidence of febrile neutropenia happened during each course of chemotherapy happened during each course of chemotherapy |
| adverse events | One year | adverse events related to G-CSF according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03 |
| progression-free survival | Five years | progression-free survival after the primary treatment of ovarian cancer |
| visits to the hospital | One years | visits to outpatient and emergency clinics |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Outcome results
None listed