Study on the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia During Concurrent Chemoradiotherapy of Cervical Cancer

Phase 2

Completed

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

• Registration Number: NCT04542356
• Lead Sponsor: Chongqing University Cancer Hospital

Brief Summary

This randomized controlled prospective study aims to explore the efficacy and safety of using (PEGylated Recombinant Human Granulocyte Stimulating Factor) PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of paclitaxel and cisplatin (TP) regimen for cervical cancer. To find out the best time to use PEG-rhG CSF, and to explore investigate the effect of PEG-rhG-CSF on long-term bone marrow function in the process of concurrent chemoradiotherapy, and finally to explore the clinical feasibility of using PEG-rhG-CSF to prevent neutropenia during concurrent chemoradiotherapy of TP regimen for cervical cancer.

Detailed Description

Study design: In this prospective, single-center, randomized controlled study, patients with locally advanced cervical cancer are randomly divided into two groups. Patients in the experimental group will receive PEG-rhG-CSF 6mg prevention during concurrent chemoradiotherapy, whereas the control group do not use PEG-rhG-CSF for prevention. When the patient's ANC is less than 1✕109/L, 5μg/kg rhG-CSF will be given for treatment until the ANC returned to 2✕109/L.

Case selection: patients with IIb-IIIb cervical cancer, squamous cell carcinoma confirmed by histopathology, and three-week regimen of paclitaxel and carboplatin with Concurrent Radiotherapy.

Primary end point: incidence and duration of grade 3/4 neutropenia in patients. Secondary endpoints: 1) Incidence of febrile neutropenia (FN); 2) the rate of postponement of the course of radiotherapy, reduction in chemotherapy dose and postponement of the course of chemotherapy; 3) Changes of bone marrow function in patients 3 months and 6 months after radiotherapy.

Safety assessment: laboratory safety testing, including platelet count and hemoglobin. Evaluation of adverse events: infection, neutropenic fever, bone pain, etc.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-02
• Study First Posted: 2020-09-09
• Primary Completion: 2021-01-26
• Study Completion: 2021-05-26
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 18-70 years old;
• Patients with cervical cancer who have not undergone surgery for initial treatment, the international union of gynecology and obstetrics (FIGO) stage IIb-IIIb; Squamous cell carcinoma diagnosed by histopathology.
• The expected survival time was more than 8 months; the Eastern Cooperative Oncology Group (ECOG) performance status score≤1;
• Bone marrow hematopoietic function is normal before treatment (ANC≥1.8×109/L, PLT≥100×109/L, Hb≥90g/L, WBC≥4.0×109/L);
• No obvious abnormality in the ECG examination, and no obvious cardiac dysfunction;
• All patients must agree to take effective contraceptive measures during the study period and within 6 months after stopping treatment, and women of childbearing age must have a negative urine pregnancy test prior to treatment administration;
• The subjects voluntarily participate in this clinical trial and sign an informed consent form.

Exclusion Criteria

• Those who refuse to accept PEG-rh-G-CSF;
• Currently conducting clinical trials of other drugs;
• Uncontrolled infection before treatment, body temperature ≥ 38℃;
• Chronic diseases of the heart, kidney, liver or other important organs;
• Patients with severe uncontrolled diabetes;
• Pregnant or lactating female patients;
• Persons with allergic diseases or allergic constitution, or allergic to this product or other biological products derived from genetically engineered E. coli;
• Suspected or confirmed drug, substance or alcohol abuse;
• Severe mental or neurological disorders that affect informed consent and/or adverse reaction presentation or observation;
• HIV-positive people;
• Patients requiring radiation therapy for the retroperitoneal or inguinal region.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	PEG-rhG-CSF	patients used 6 mg PEG-rhG-CSF prophylactically after chemotherapy
control group	rhG-CSF	patients did not use PEG-rhG-CSF for prevention and were given 5 ug/kg rhG-CSF when ANC\<1✕109/L

Primary Outcome Measures

Name	Time	Method
Duration of grade 3-4 neutropenia	2 months	Duration of grade 3-4 neutropenia
Incidence of Grade 3-4 neutropenia	2 months	Incidence of Grade 3-4 neutropenia

Secondary Outcome Measures

Name	Time	Method
postponement of the course of chemotherapy	2 months	postponement of the course of chemotherapy
Incidence of febrile neutropenia (FN)	2 months	Incidence of febrile neutropenia (FN)
the rate of postponement of the course of radiotherapy	2 months	the rate of postponement of the course of radiotherapy
reduction in chemotherapy dose	2 months	reduction in chemotherapy dose
Changes of bone marrow function in patients 3 months and 6 months after radiotherapy	6 months	Changes of bone marrow function in patients 3 months and 6 months after radiotherapy

Trial Locations

Locations (1)

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China