Clinical trial · Interventional
Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Neutropenia | — | UNRESOLVED | — |
| Colony Stimulating Factors Adverse Reaction | — | UNRESOLVED | — |
| Cost-effectiveness Analysis | — | UNRESOLVED | — |
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Febrile Neutropenia, Drug-Induced | — | UNRESOLVED | — |
| Granulocyte Colony Stimulating Factor | — | UNRESOLVED | — |
| Overall Survival | — | UNRESOLVED | — |
| Progression-free Survival | — | UNRESOLVED | — |
| Quality of Life |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Long-acting granulocyte colony stimulating factor | Drug | — | UNRESOLVED |
| Short-acting granulocyte colony stimulating factor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study group
- description
- Patients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor
- interventionNames
- Drug: Long-acting granulocyte colony stimulating factor
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Patients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines
- interventionNames
- Drug: Short-acting granulocyte colony stimulating factor
Primary outcomes (1)
- measure
- Incidence of febrile neutropenia
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available