Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies
NCT ID: NCT04773327
Last Updated: 2021-02-26
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
NA
150 participants
INTERVENTIONAL
2021-05-31
2022-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PEG-rhG-CSF prevention
Mecapegfilgrastim subcutaneous injection, 6mg, 24-48h after the end of antitumor drug administration in each chemotherapy cycle,
Mecapegfilgrastim Injection
24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle
non-prevention
Only close monitoring after chemotherapy
No interventions assigned to this group
Interventions
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Mecapegfilgrastim Injection
24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. Hb≥75g/L; WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥80×109/L;
2. APTT-ULN≤10s; PT-ULN≤3s; TT-ULN≤3s;
3. ALT≤2.5×ULN; AST≤2.5×ULN; TBIL≤2.5×ULN;
4. BUN≤1.5×ULN; Cr≤1.5×ULN; UA≤1.5×ULN；Creatinine clearance≥40mL/min;
5. without obvious cardiac dysfunction
* Provided consent for participation
Exclusion Criteria
* Pregnant or lactating women
* Received bone marrow or hematopoietic stem cell transplantation within the past 3 months
* Concurrent chemoradiotherapy
* Presence of hematological disorders: systemic lupus erythematosus, sjogren's syndrome, rheumatic autoimmune disease, mixed and hoof tissue disease, autoimmune hemolytic anemia, leukopenia , chronic granulocyte leukemia, bone marrow dysplasia syndrome, aplastic anemia, congenital and idiopathic neutropenia, myelodysplastic syndrome, cyclic neutropenia, primary and secondary thrombocytopenic purpura, etc
* Presence of risk of thrombus or high risk of clotting
* Presence of psychosis, neurological disease or brain metastases from tumors
* Presence of uncontrollable complicated disease including symptomatic congestive heart failure, uncontrollable hypertension, unstable angina pectoris, active peptic ulcer, or hemorrhagic disease
* Presence of uncontrollable infectious diseases, active viral hepatitis, tuberculosis, HIV
* Allergic to recombinant human granulocyte stimulating factor or other biological products of E. coli origin
* Received clinical trials within 1 month prior to enrollment
18 Years
70 Years
ALL
No
Sponsors
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Xiaohua Wu MD
OTHER
Responsible Party
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Xiaohua Wu MD
director of gynecologic oncology
Principal Investigators
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Xiaohua Wu, MD&PHD
Role: PRINCIPAL_INVESTIGATOR
director of gynecologic oncology
Locations
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No. 270, Dongan Road, Xuhui District, Shanghai, China
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xiaohua Wu
Role: primary
Other Identifiers
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MA-GynC-II-001
Identifier Type: -
Identifier Source: org_study_id