Clinical trial NCT04542356: Study on the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia During Concurrent Chemoradiotherapy of Cervical Cancer
Official title: Efficacy and Safety of PEGylated Recombinant Human Granulocyte Stimulating Factor in the Prevention of Neutropenia During Concurrent Chemoradiotherapy for Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: Cervical Cancer
concurrent chemoradiotherapy
neutropenia
PEG-rhG-CSF
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Grade 3-4 neutropenia
timeFrame: 2 months
measure: Duration of grade 3-4 neutropenia
timeFrame: 2 months
Secondary outcomes:
measure: Incidence of febrile neutropenia (FN)
timeFrame: 2 months
measure: the rate of postponement of the course of radiotherapy
timeFrame: 2 months
measure: reduction in chemotherapy dose
timeFrame: 2 months
measure: postponement of the course of chemotherapy
timeFrame: 2 months
measure: Changes of bone marrow function in patients 3 months and 6 months after radiotherapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
Study officials:
affiliation: Chongqing University Cancer Hospital
name: Dongling Zou, M.D.
role: PRINCIPAL_INVESTIGATOR
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citation: Zou D, Guo M, Zhou Q. A clinical study of pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) in preventing neutropenia during concurrent chemoradiotherapy of cervical cancer. BMC Cancer. 2021 Jun 2;21(1):661. doi: 10.1186/s12885-021-08364-9.