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This study is a multi-center, forward-looking, open, randomized, controlled clinical trial. This study aims to analyze the effects of Mecapegfilgrastim Injection prevention versus non-prevention for neutropenia in ovarian cancer, cervical cancer, endometrial cancer patients after chemical therapy.
Patients are randomized into study group and control group. All patients receive PTX+platinum chemotherapy of 3 weeks. In study group, patients accept PEG-rhG-CSF 24-48 hours from the chemotherapy. While the control group patients are only observed closely. Patient receive three courses of treatment.
The primary end is the incidence of 3/4 level neutropenia in three courses of chemotherapy.
The secondary ends include: the incidences and duration of neutropenia in every course of chemotherapy, the incidences of FN in three courses and every course of chemotherapy, the incidences of infection in three courses and every course of chemotherapy, the delay time of the next cycle of chemotherapy due to FN or infection, the RDI of the second and third cycles of chemotherapy, adverse events related to G-CSF, quality of life, cost of medicine and admitting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhG-CSF prevention | Experimental | Mecapegfilgrastim subcutaneous injection, 6mg, 24-48h after the end of antitumor drug administration in each chemotherapy cycle, |
|
| non-prevention | No Intervention | Only close monitoring after chemotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mecapegfilgrastim Injection | Other | 24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of third/fourth level neutropenia | Incidence of third/fourth level neutropenia during three cycles chemotherapy | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia | Incidence of febrile neutropenia during every cycle chemotherapy | three months |
| The duration time of third/fourth level neutropenia | The duration time of third/fourth level neutropenia during three cycles chemotherapy |
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Inclusion Criteria:
Ages 18-70
Weight ≥45 kg
≤2 lines chemotherapy or postoperative adjuvant chemotherapy patients with cervical cancer, ovarian cancer and endometrial cancer
Receive paclitaxel combined with platinum three weeks per cycle of chemotherapy
With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
Expected survival time of > 3 months
Main organ functions meet the following criteria:
Provided consent for participation
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingfang Xia, M.D. | Contact | 13774211977 | nightxlf@163.com | |
| Xiaohua Wu, MD&PHD | Contact | +862164175590 | alizheng@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohua Wu, MD&PHD | director of gynecologic oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 270, Dongan Road, Xuhui District, Shanghai, China | Shanghai | Shanghai Municipality | China |
data is available per require after approved by ethics broad
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| ID | Term |
|---|---|
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
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|
| three months |
| Incidence of infection | Incidence of third/fourth level neutropenia during three cycles chemotherapy | three months |
| delay time of chemotherapy | The delay time of the next cycle of chemotherapy due to FN or infection | three months |
| RDI of chemotherapy | Relative dose intensity of the second and third chemotherapy | three months |
| Adverse events | Incidence of adverse events related to granulocyte colony stimulating factor according to common Terminology Criteria for Adverse Events (CTCAE) v5.0 | three months |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |