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

Last updated: October 5, 2019
Sponsor: Lei Li
Overall Status: Active - Recruiting

Phase

3

Condition

Ovarian Cysts

Neutropenia

Effects Of Chemotherapy

Treatment

N/A

Clinical Study ID

NCT04101760
EOC-CSF
  • Ages > 18
  • All Genders

Study 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

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 debulkingsurgery

  • Regularly followed up in the study centers

  • Provided consent for participation.

Exclusion

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 acquiredimmune deficiency syndrome

  • Treated with weekly chemotherapy regimens

  • Presence of hematological disorders

Study Design

Total Participants: 200
Study Start date:
October 01, 2019
Estimated Completion Date:
October 01, 2020

Connect with a study center

  • Lei Li

    Beijing, Beijing 100730
    China

    Active - Recruiting

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