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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 : Recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Beihua Kong, Shandong University

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.

Condition or disease Intervention/treatment Phase
Adjuvant Chemotherapy Ovarian Neoplasms Ovarian Cancer Drug: PEG-rhG-CSF Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Secondary Prophylaxis Versus ANC< 1000/mm3 Administration of PEG-rhG-CSF in Patients Receiving Cytotoxic Chemotherapy for Gynecologic Malignancies
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Active Comparator: Standard group
6mg PEG-rhG-CSF was administrated subcutaneously in 24h after chemotherapy.
Drug: PEG-rhG-CSF
6mg PEG-rhG-CSF was administrated subcutaneously at different time after chemotherapy.

Experimental: Adjusted group
6mg PEG-rhG-CSF was administrated subcutaneously when ANC < 1000/mm3 after chemotherapy.
Drug: PEG-rhG-CSF
6mg PEG-rhG-CSF was administrated subcutaneously at different time after chemotherapy.




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858166


Contacts
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Contact: Beihua Kong, MD, PhD +8618560081888 kongbeihua@sdu.edu.cn

Locations
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China, Shandong
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Beihua Kong, MD, PhD    +8653182169562      
Sponsors and Collaborators
Shandong University

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Responsible Party: Beihua Kong, Clinical Professor, Shandong University
ClinicalTrials.gov Identifier: NCT03858166     History of Changes
Other Study ID Numbers: WJW-2-PEG-OC
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Beihua Kong, Shandong University:
PEG-rhG-CSF
secondary prophylaxis

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type