Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer
NCT ID: NCT04101760
Last Updated: 2019-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2019-10-01
2020-10-01
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study group
Patients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor
Long-acting granulocyte colony stimulating factor
Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy
Control group
Patients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines
Short-acting granulocyte colony stimulating factor
Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns
Interventions
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Long-acting granulocyte colony stimulating factor
Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy
Short-acting granulocyte colony stimulating factor
Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
18 Years
ALL
No
Sponsors
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Beijing Hospital
OTHER_GOV
China-Japan Friendship Hospital
OTHER
Navy General Hospital, Beijing
OTHER
Seventh Medical Center of PLA Army General Hospital
OTHER
Lei Li
OTHER
Responsible Party
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Lei Li
Professor
Principal Investigators
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Lei Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Lei Li
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EOC-CSF
Identifier Type: -
Identifier Source: org_study_id
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