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

Primary Purpose

Cervical Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
PEG-rhG-CSF
rhG-CSF
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEG-rhG-CSF

rhG-CSF

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of III/IV neutropenia
The incidence of III/IV neutropenia in each chemotherapy cycle

Secondary Outcome Measures

Incidence of FN
Incidence of febrile neutropenia (FN) in each chemotherapy cycle
Proportion of chemotherapy dose adjustment
Proportion of chemotherapy dose adjustment due to neutropenia

Full Information

First Posted
June 30, 2017
Last Updated
August 25, 2017
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT03206684
Brief Title
To Evaluate the Efficacy and Safety of PEG-rhG-CSF（Jinyouli®） in Reducing Neutropenia in Patients With Cervical Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2017 (Anticipated)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

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

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEG-rhG-CSF
Arm Type
Experimental
Arm Description
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.
Arm Title
rhG-CSF
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
PEG-rhG-CSF
Other Intervention Name(s)
PEG-rhG-CSF single-dose administered
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
rhG-CSF
Other Intervention Name(s)
rhG-CSF daily administered
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of III/IV neutropenia
Description
The incidence of III/IV neutropenia in each chemotherapy cycle
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Incidence of FN
Description
Incidence of febrile neutropenia (FN) in each chemotherapy cycle
Time Frame
3 months
Title
Proportion of chemotherapy dose adjustment
Description
Proportion of chemotherapy dose adjustment due to neutropenia
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18, ≤70 years old; Cervical cancer patients diagnosed by histopathology; Need to receive multi-cycle radical concurrent radiochemotherapy; 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)； Performance status score(KPS)≥70; 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; The patient signs the informed consent. Exclusion Criteria: With infection difficult to control, or received system antibiotic treatment within 72 h before chemotherapy; Any bone marrow abnormalities and other hematopoietic ; Had received bone marrow or hematopoietic stem cell transplantation within 3 months; with other malignancies not cure, or with brain metastases; Liver function tests:total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≥2.5 times normal upper limit. Renal function tests: serum creatinine (Cr)> 1.5 times normal upper limit; Allergic to the drugs or other genetic engineering biological products from Escherichia coli; Suffering from mental or neurological disorders; Investigator think it is not suitable for recruiting.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei Shi, MD
Phone
+86-29-84775425
Email
Shimei82@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei Shi, MD
Organizational Affiliation
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Shi, MD
Phone
+86-029-84775425
Email
Shimei82@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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