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

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ClinicalTrials.gov Identifier: NCT03206684
Recruitment Status : Unknown
Verified August 2017 by Mei Shi, Fourth Military Medical University.
Recruitment status was:  Not yet recruiting
First Posted : July 2, 2017
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
Mei Shi, Fourth Military Medical University

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
Cervical Cancer Drug: PEG-rhG-CSF Drug: rhG-CSF Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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 Name: 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 Name: rhG-CSF daily administered




Primary Outcome Measures :
  1. Incidence of III/IV neutropenia [ Time Frame: 3 months ]
    The incidence of III/IV neutropenia in each chemotherapy cycle


Secondary Outcome Measures :
  1. Incidence of FN [ Time Frame: 3 months ]
    Incidence of febrile neutropenia (FN) in each chemotherapy cycle

  2. Proportion of chemotherapy dose adjustment [ Time Frame: 3 months ]
    Proportion of chemotherapy dose adjustment due to neutropenia



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)≥ 1.5×10^9/L, platelet count≥80×10^9 /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.

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): NCT03206684


Contacts
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Contact: Mei Shi, MD +86-29-84775425 Shimei82@gmail.com

Locations
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China, Shaanxi
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University Not yet recruiting
Xi'an, Shaanxi, China, 710032
Contact: Mei Shi, MD    +86-029-84775425    Shimei82@gmail.com   
Sponsors and Collaborators
Fourth Military Medical University
Investigators
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Principal Investigator: Mei Shi, MD Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

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Responsible Party: Mei Shi, Professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT03206684     History of Changes
Other Study ID Numbers: CSPC-JYL-CC-01
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Neutropenia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases