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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of PEGylated Recombinant Human Granulocyte Stimulating Factor in the Prevention of Neutropenia During Concurrent Chemoradiotherapy for Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: PEG-rhG-CSF
* Drug: rhG-CSF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>patients used 6 mg PEG-rhG-CSF prophylactically after chemotherapy | Drug: PEG-rhG-CSF<br>* During the concurrent chemoradiotherapy, a single subcutaneous injection of 6 mg PEG-rhG-CSF was given to the patient 2 hours after radiotherapy on the first day after the end of chemotherapy. Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.<br>|
| Placebo Comparator: control group<br>patients did not use PEG-rhG-CSF for prevention and were given 5 ug/kg rhG-CSF when ANC<1✕109/L | Drug: rhG-CSF<br>* Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Grade 3-4 neutropenia | Incidence of Grade 3-4 neutropenia | 2 months | 
| Duration of grade 3-4 neutropenia | Duration of grade 3-4 neutropenia | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of febrile neutropenia (FN) | Incidence of febrile neutropenia (FN) | 2 months | 
| the rate of postponement of the course of radiotherapy | the rate of postponement of the course of radiotherapy | 2 months | 
| reduction in chemotherapy dose | reduction in chemotherapy dose | 2 months | 
| postponement of the course of chemotherapy | postponement of the course of chemotherapy | 2 months | 
| Changes of bone marrow function in patients 3 months and 6 months after radiotherapy | Changes of bone marrow function in patients 3 months and 6 months after radiotherapy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Cancer, concurrent chemoradiotherapy, neutropenia, PEG-rhG-CSF