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

Phase 4

• Conditions: Cervical Cancer
• Interventions: Drug: PEG-rhG-CSF; Drug: rhG-CSF

• Registration Number: NCT03206684
• Lead Sponsor: Air Force Military Medical University, China

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 available

Study Timeline

• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-06-30
• Study First Posted: 2017-07-02
• Status Verified: 2017-08
• Study Start: 2017-08
• Last Update Submitted: 2017-08-25
• Last Update Posted: 2017-08-28
• Primary Completion: 2018-07
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-rhG-CSF	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.
rhG-CSF	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.

Primary Outcome Measures

Name	Time	Method
Incidence of III/IV neutropenia	3 months	The incidence of III/IV neutropenia in each chemotherapy cycle

Secondary Outcome Measures

Name	Time	Method
Incidence of FN	3 months	Incidence of febrile neutropenia (FN) in each chemotherapy cycle
Proportion of chemotherapy dose adjustment	3 months	Proportion of chemotherapy dose adjustment due to neutropenia

Trial Locations

Locations (1)

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China