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To Evaluate the Efficacy and Safety of PEG-rhG-CSF（Jinyouli®） in Reducing Neutropenia in Patients With Cervical Cancer

Sponsor
Air Force Military Medical University, China (Other)
Overall Status
Unknown status
CT.gov ID
NCT03206684
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection) in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous radiochemotherapy and adjuvant chemotherapy in patients with cervical cancer

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Open, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF in Reducing Neutropenia in Patients With Cervical Cancer
Anticipated Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Jul 1, 2018
Anticipated Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: PEG-rhG-CSF

PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy，with patients' weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight <45kg were given 3mg once per chemotherapy cycle.

Drug: PEG-rhG-CSF
PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy，weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight <45kg were given 3mg once per chemotherapy cycle.
Other Names:
  • PEG-rhG-CSF single-dose administered

    		•
    Active Comparator: rhG-CSF

    rhG-CSF was daily administered subcutaneously 48h after chemotherapy，weight≥45kg were given 300μg/d, weight<45kg were given 150μg/d,continuous injection for 3-5 days until the absolute neutrophils count≥2×10^9/L.

    Drug: rhG-CSF
    rhG-CSF was administered subcutaneously 48h after chemotherapy，weight≥45kg were given 300μg/d, weight<45kg were given 150μg/d,continuous injection for 3-5 days until the absolute neutrophils count≥2×10^9/L.
    Other Names:
  • rhG-CSF daily administered

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of III/IV neutropenia [3 months]

      The incidence of III/IV neutropenia in each chemotherapy cycle

    Secondary Outcome Measures

    1. Incidence of FN [3 months]

      Incidence of febrile neutropenia (FN) in each chemotherapy cycle

    2. Proportion of chemotherapy dose adjustment [3 months]

      Proportion of chemotherapy dose adjustment due to neutropenia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age ≥18, ≤70 years old;

    2. Cervical cancer patients diagnosed by histopathology;

    3. Need to receive multi-cycle radical concurrent radiochemotherapy;

    4. FN risk > 20% if rhG-CSF was not accepted; High risk factors associated with FN and planed to use the same protocol in subsequent cycles(docetaxel+cisplatin regimen)；

    5. Performance status score(KPS)≥70;

    6. No obvious blood system disease,absolute neutrophil count（ANC）≥ 1.5×109/L, platelet count≥80×109 /L, hemoglobin（Hb）≥75 g/L, and no bleeding tendency;

    7. The patient signs the informed consent.

    Exclusion Criteria:

    1. With infection difficult to control, or received system antibiotic treatment within 72 h before chemotherapy;

    2. Any bone marrow abnormalities and other hematopoietic ;

    3. Had received bone marrow or hematopoietic stem cell transplantation within 3 months;

    4. with other malignancies not cure, or with brain metastases;

    5. Liver function tests:total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≥2.5 times normal upper limit.

    6. Renal function tests: serum creatinine (Cr)> 1.5 times normal upper limit;

    7. Allergic to the drugs or other genetic engineering biological products from Escherichia coli;

    8. Suffering from mental or neurological disorders;

    9. Investigator think it is not suitable for recruiting.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • Air Force Military Medical University, China

    Investigators

    • Principal Investigator: Mei Shi, MD, Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mei Shi, Professor, Air Force Military Medical University, China
    ClinicalTrials.gov Identifier:
    NCT03206684
    Other Study ID Numbers:
    • CSPC-JYL-CC-01
    First Posted:
    Jul 2, 2017
    Last Update Posted:
    Aug 28, 2017
    Last Verified:
    Aug 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Neutropenia

    Study Results

    No Results Posted as of Aug 28, 2017