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

NCT03206684 | Unknown Phase 4

• 1 other identifier: CSPC-JYL-CC-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of III/IV neutropenia

  The incidence of III/IV neutropenia in each chemotherapy cycle

  3 months

Secondary Outcomes (2)

• Incidence of FN

  3 months

• Proportion of chemotherapy dose adjustment

  3 months

Study Arms (2)

PEG-rhG-CSF

EXPERIMENTAL

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

rhG-CSF

ACTIVE COMPARATOR

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

Interventions

PEG-rhG-CSF DRUG

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.

Also known as: PEG-rhG-CSF single-dose administered

PEG-rhG-CSF

rhG-CSF DRUG

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.

Also known as: rhG-CSF daily administered

rhG-CSF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

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

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Mei Shi, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Shi, MD

CONTACT

+86-29-84775425; Shimei82@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: August 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CN (1)