Status:
TERMINATED
Efficacy and Safety of PEG-rhG-CSF Secondary Prophylaxis vs. Therapeutic Administration in Patients With Ovarian Cancer
Lead Sponsor:
Shandong University
Conditions:
Adjuvant Chemotherapy
Ovarian Neoplasms
Eligibility:
FEMALE
18-80 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03858166
Start Date
December 1 2017
End Date
December 31 2020
Last Update
January 5 2024
Active Locations (1)
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1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012