Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 30, 2017
First Posted Date  ICMJE July 2, 2017
Last Update Posted Date August 28, 2017
Estimated Study Start Date  ICMJE August 2017
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2017)
Incidence of III/IV neutropenia [ Time Frame: 3 months ]
The incidence of III/IV neutropenia in each chemotherapy cycle
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03206684 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2017)
  • Incidence of FN [ Time Frame: 3 months ]
    Incidence of febrile neutropenia (FN) in each chemotherapy cycle
  • Proportion of chemotherapy dose adjustment [ Time Frame: 3 months ]
    Proportion of chemotherapy dose adjustment due to neutropenia
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Efficacy and Safety of PEG-rhG-CSF(Jinyouli®) in Reducing Neutropenia in Patients With Cervical Cancer
Official Title  ICMJE 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
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
Detailed Description Not Provided
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 Cervical Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: PEG-rhG-CSF
  • 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.
    Intervention: Drug: 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: June 30, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 NCT03206684
Other Study ID Numbers  ICMJE CSPC-JYL-CC-01
Has Data Monitoring Committee Not Provided
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 Mei Shi, Fourth Military Medical University
Study Sponsor  ICMJE Fourth Military Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mei Shi, MD Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
PRS Account Fourth Military Medical University
Verification Date August 2017

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