study on the efficacy and safety of peg-rhg-csf in preventing neutropenia during concurrent chemoradiotherapy of cervical cancer

Conditions: Cervical Cancer

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.

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.

Keywords: cervical cancer concurrent chemoradiotherapy neutropenia peg-rhg-csf