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

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ClinicalTrials.gov Identifier: NCT03858166
Recruitment Status : Unknown
Verified February 2019 by Beihua Kong, Shandong University.
Recruitment status was:  Recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Beihua Kong, Shandong University

Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE February 28, 2019
Last Update Posted Date February 28, 2019
Actual Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • Incidence of grade 3/4 neutropenia [ Time Frame: At the end of cycle 2 (each cycle is 21 days) ]
    Incidence of grade 3/4 neutropenia
  • The duration of grade 3/4 neutropenia [ Time Frame: At the end of cycle 2 (each cycle is 21 days) ]
    The duration of grade 3/4 neutropenia
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of PEG-rhG-CSF Secondary Prophylaxis vs. Therapeutic Administration in Patients With Ovarian Cancer
Official Title  ICMJE The Efficacy and Safety of Secondary Prophylaxis Versus ANC< 1000/mm3 Administration of PEG-rhG-CSF in Patients Receiving Cytotoxic Chemotherapy for Gynecologic Malignancies
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 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adjuvant Chemotherapy
  • Ovarian Neoplasms
  • Ovarian Cancer
Intervention  ICMJE Drug: PEG-rhG-CSF
6mg PEG-rhG-CSF was administrated subcutaneously at different time after chemotherapy.
Study Arms  ICMJE
  • Active Comparator: Standard group
    6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy.
    Intervention: Drug: PEG-rhG-CSF
  • Experimental: Adjusted group
    6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy.
    Intervention: Drug: PEG-rhG-CSF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 27, 2019)
1190
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged 18 years or older
  2. Histopathology or cytology and immunomolecular biology diagnosed with ovarian cancer
  3. Grade 3/4 neutropenia appeared in previous chemotherapy
  4. accept at least 3 cycles of adjuvant chemotherapy
  5. expected survival time ≥ 8 months; KPS>70
  6. Normal bone marrow hematopoietic function: ANC≥1.5×109/L, PLT≥80×109/L, Hb≥75g/L, WBC ≥3.0×109/L
  7. No obvious abnormalities in electrocardiogram examination, no obvious cardiac dysfunction
  8. Liver function: ALT, TBIL, AST <= 2.5 ULN
  9. Renal function: Cr, BUN <= 1.5 ULN
  10. 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.
  11. Before the start of the study, all patients have been fully understood the research and the must sign the informed consent.

Exclusion Criteria:

  1. Uncontrolled infection, temperature≥38℃
  2. patients with bone marrow dysplasia and other hematopoietic dysfunction , or accepted stem cell or bone marrow transplant in 3 months before recruitment
  3. undergoing any other clinical trial in 4 weeks before recruitment
  4. undergoing radiotherapy in 4 weeks before recruitment
  5. Patients with other malignant tumors who have not been cured or have brain metastasis
  6. 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
  7. Severe heart, kidney, liver and other important organs chronic diseases
  8. severe and uncontrolled diabetes
  9. Pregnancy or lactation in women or women of childbearing age refused to accept contraception
  10. People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products
  11. Suspected or confirmed drug use, drug abuse, alcoholics
  12. Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation
  13. HIV positive
  14. Syphilis infection
  15. The investigator believes that the patient's condition is not suitable for this clinical study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03858166
Other Study ID Numbers  ICMJE WJW-2-PEG-OC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beihua Kong, Shandong University
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shandong University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP