Efficacy and Safety of PEG-rhG-CSF Secondary Prophylaxis vs. Therapeutic Administration in Patients With Ovarian Cancer

Study Overview
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Brief Summary
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This study is a multicenter, open-label, randomized clinical trial. Patients with ovarian cancer receiving postoperative adjuvant chemotherapy were eligible to enroll in this study. Eligible patients were randomly allocated in a 1:1 to Standard group ( 6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy) and Adjusted group (6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy). All patients need to receive at least 2 cycles of PEG-rhG-CSF administration. The primary outcome is the incidence of grade 3/4 neutropenia, and the duration of grade 3/4 neutropenia, the second outcomes are the incidence of FN, neutropenia-related hospitalization, incidence of reduction and delay of chemotherapy dose and safety of PEG-rhG-CSF.

Detailed Description
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Patients with ovarian cancer receiving postoperative adjuvant chemotherapy were recruited and randomly allocated in a 1:1 to Standard group (6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy) and Adjusted group (6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy). Eligible patients enrolled in this study need to receive 6 cycles of docetaxel or paclitaxel (including liposome paclitaxel) and carboplatin on day 1, every 3 weeks. All patients need to receive at least 2 cycles of PEG-rhG-CSF administration. The primary outcome is the incidence of grade 3/4 neutropenia, and the duration of grade 3/4 neutropenia, the second outcomes are the incidence of FN, neutropenia-related hospitalization, incidence of reduction and delay of chemotherapy dose and safety of PEG-rhG-CSF.

Official Title
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The Efficacy and Safety of Secondary Prophylaxis Versus ANC< 1000/mm3 Administration of PEG-rhG-CSF in Patients Receiving Cytotoxic Chemotherapy for Gynecologic Malignancies

Conditions
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Adjuvant Chemotherapy, Ovarian Neoplasms, Ovarian Cancer

Intervention / Treatment
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* Drug: PEG-rhG-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or older Histopathology or cytology and immunomolecular biology diagnosed with ovarian cancer Grade 3/4 neutropenia appeared in previous chemotherapy accept at least 3 cycles of adjuvant chemotherapy expected survival time ≥ 8 months; KPS>70 Normal bone marrow hematopoietic function: ANC≥1.5×109/L, PLT≥80×109/L, Hb≥75g/L, WBC ≥3.0×109/L No obvious abnormalities in electrocardiogram examination, no obvious cardiac dysfunction Liver function: ALT, TBIL, AST <= 2.5 ULN Renal function: Cr, BUN <= 1.5 ULN All patients must agree to take effective contraceptive measures during the study and within 6 months after discontinuing the treatment. Females of childbearing age must be negative in urinary pregnancy test before the treatment. Before the start of the study, all patients have been fully understood the research and the must sign the informed consent. Exclusion Criteria: Uncontrolled infection, temperature≥38℃ patients with bone marrow dysplasia and other hematopoietic dysfunction , or accepted stem cell or bone marrow transplant in 3 months before recruitment undergoing any other clinical trial in 4 weeks before recruitment undergoing radiotherapy in 4 weeks before recruitment Patients with other malignant tumors who have not been cured or have brain metastasis Liver function: ALT, TBIL, AST > 2.5 ULN; If due to liver metastasis, ALT, TBIL, AST > 5 ULN; Renal function: Cr>1.5; Obvious abnormalities in electrocardiogram Severe heart, kidney, liver and other important organs chronic diseases severe and uncontrolled diabetes Pregnancy or lactation in women or women of childbearing age refused to accept contraception People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products Suspected or confirmed drug use, drug abuse, alcoholics Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation HIV positive Syphilis infection The investigator believes that the patient's condition is not suitable for this clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard group<br>6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy. | Drug: PEG-rhG-CSF<br>* 6mg PEG-rhG-CSF was administrated subcutaneously at different time after chemotherapy.<br>|
| Experimental: Adjusted group<br>6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy. | Drug: PEG-rhG-CSF<br>* 6mg PEG-rhG-CSF was administrated subcutaneously at different time after chemotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of grade 3/4 neutropenia | Incidence of grade 3/4 neutropenia | At the end of cycle 2 (each cycle is 21 days) | 
| The duration of grade 3/4 neutropenia | The duration of grade 3/4 neutropenia | At the end of cycle 2 (each cycle is 21 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG-rhG-CSF, secondary prophylaxis