Clinical trial NCT04773327: Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies
Official title: A Multicenter, Randomized Controlled, Open Clinical Study of the Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemotherapy in Patients With Gynecological Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Malignant Tumor
Keywords: neutropenia
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of third/fourth level neutropenia
timeFrame: three months
Secondary outcomes:
measure: Incidence of febrile neutropenia
timeFrame: three months
measure: The duration time of third/fourth level neutropenia
timeFrame: three months
measure: Incidence of infection
timeFrame: three months
measure: delay time of chemotherapy
timeFrame: three months
measure: RDI of chemotherapy
timeFrame: three months
measure: Adverse events
timeFrame: three months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: No. 270, Dongan Road, Xuhui District, Shanghai, China
state: Shanghai
Study officials:
affiliation: director of gynecologic oncology
name: Xiaohua Wu, MD&PHD
role: PRINCIPAL_INVESTIGATOR
References: