Gynecologic Malignant Tumor
Conditions
Keywords
neutropenia
Brief summary
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.
Interventions
24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle
Sponsors
Xiaohua Wu MD
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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: 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
* With uncontrollable infections or receive systemic antibiotics within 72 hours prior to chemotherapy * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of third/fourth level neutropenia | three months | Incidence of third/fourth level neutropenia during three cycles chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The duration time of third/fourth level neutropenia | three months | The duration time of third/fourth level neutropenia during three cycles chemotherapy |
| Incidence of infection | three months | Incidence of third/fourth level neutropenia during three cycles chemotherapy |
| Incidence of febrile neutropenia | three months | Incidence of febrile neutropenia during every cycle chemotherapy |
| RDI of chemotherapy | three months | Relative dose intensity of the second and third chemotherapy |
| Adverse events | three months | Incidence of adverse events related to granulocyte colony stimulating factor according to common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| delay time of chemotherapy | three months | The delay time of the next cycle of chemotherapy due to FN or infection |
Countries
China
Contacts
Primary ContactLingfang Xia, M.D.
Backup ContactXiaohua Wu, MD&PHD
Outcome results
None listed