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| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
| China-Japan Friendship Hospital | OTHER |
| Navy General Hospital, Beijing | OTHER |
| Seventh Medical Center of PLA Army General Hospital |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Patients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor |
|
| Control group | Active Comparator | Patients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long-acting granulocyte colony stimulating factor | Drug | Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia | Incidence of febrile neutropenia during each course of chemotherapy | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of myelosuppression | Incidence of febrile neutropenia during each course of chemotherapy | One year |
| Doses of granulocyte colony stimulating factor | Doses of long-acting and short-acting granulocyte colony stimulating factor used during each course of chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li, M.D. | Contact | +8613911988831 | lileigh@163.com | |
| Ming Wu, M.D. | Contact | +8613801224549 | wuming@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lei Li, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 100730 | China |
The individual participant data will be shared as a supplement along with the published papers.
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| OTHER |
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| Short-acting granulocyte colony stimulating factor | Drug | Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns |
|
| One year |
| Numbers of visits to the hospital | Visits to the outpatient clinics and emergency room | One year |
| Adverse events | Incidence of adverse events related to granulocyte colony stimulating factor according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | One years |
| Progression-free survival | Progression-free survival after the treatment of ovarian cancer during the study periods | Two years |
| Overall survival | Overall survival after the treatment of ovarian cancer during the study periods | Two years |
| ID | Term |
|---|---|
| D064146 | Chemotherapy-Induced Febrile Neutropenia |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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