Clinical trial NCT04101760: Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer
Official title: Long-acting Versus Short-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer Patients: A Multicenter Phase 3 Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chemotherapy-induced Neutropenia
Febrile Neutropenia, Drug-Induced
Epithelial Ovarian Cancer
Colony Stimulating Factors Adverse Reaction
Granulocyte Colony Stimulating Factor
Cost-effectiveness Analysis
Quality of Life
Progression-free Survival
Overall Survival
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Hospital
name: China-Japan Friendship Hospital
name: Navy General Hospital, Beijing
name: Seventh Medical Center of PLA Army General Hospital
First posted: 2019-09-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Incidence of febrile neutropenia
timeFrame: One year
Secondary outcomes:
measure: Incidence of myelosuppression
timeFrame: One year
measure: Doses of granulocyte colony stimulating factor
timeFrame: One year
measure: Numbers of visits to the hospital
timeFrame: One year
measure: Adverse events
timeFrame: One years
measure: Progression-free survival
timeFrame: Two years
measure: Overall survival
timeFrame: Two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: