Overview

Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer

Status:
Unknown status
Trial end date:
2020-10-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lei Li
Collaborators:
Beijing Hospital
China-Japan Friendship Hospital
Seventh Medical Center of PLA Army General Hospital
the Seventh Medical Center of PLA General Hospital
The Sixth Medical Center of PLA General Hospital
Treatments:
Lenograstim
Sargramostim
Criteria
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