Cervical Cancer
Conditions
Keywords
Cervical Cancer, concurrent chemoradiotherapy, neutropenia, PEG-rhG-CSF
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.
Interventions
DRUGPEG-rhG-CSF
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.
DRUGrhG-CSF
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.
Sponsors
Chongqing University Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade 3-4 neutropenia | 2 months | Incidence of Grade 3-4 neutropenia |
| Duration of grade 3-4 neutropenia | 2 months | Duration of grade 3-4 neutropenia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reduction in chemotherapy dose | 2 months | reduction in chemotherapy dose |
| Incidence of febrile neutropenia (FN) | 2 months | Incidence of febrile neutropenia (FN) |
| 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 |
| postponement of the course of chemotherapy | 2 months | postponement of the course of chemotherapy |
| the rate of postponement of the course of radiotherapy | 2 months | the rate of postponement of the course of radiotherapy |
Countries
China
Outcome results
None listed