Cervical Cancer
Conditions
Brief summary
A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection) in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous radiochemotherapy and adjuvant chemotherapy in patients with cervical cancer
Interventions
DRUGPEG-rhG-CSF
PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy，weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight \<45kg were given 3mg once per chemotherapy cycle.
DRUGrhG-CSF
rhG-CSF was administered subcutaneously 48h after chemotherapy，weight≥45kg were given 300μg/d, weight\<45kg were given 150μg/d,continuous injection for 3-5 days until the absolute neutrophils count≥2×10\^9/L.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18, ≤70 years old; 2. Cervical cancer patients diagnosed by histopathology; 3. Need to receive multi-cycle radical concurrent radiochemotherapy; 4. FN risk \> 20% if rhG-CSF was not accepted; High risk factors associated with FN and planed to use the same protocol in subsequent cycles(docetaxel+cisplatin regimen)； 5. Performance status score(KPS)≥70; 6. No obvious blood system disease,absolute neutrophil count（ANC）≥ 1.5×10\^9/L, platelet count≥80×10\^9 /L, hemoglobin（Hb）≥75 g/L, and no bleeding tendency; 7. The patient signs the informed consent.
Exclusion criteria
1. With infection difficult to control, or received system antibiotic treatment within 72 h before chemotherapy; 2. Any bone marrow abnormalities and other hematopoietic ; 3. Had received bone marrow or hematopoietic stem cell transplantation within 3 months; 4. with other malignancies not cure, or with brain metastases; 5. Liver function tests:total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≥2.5 times normal upper limit. 6. Renal function tests: serum creatinine (Cr)\> 1.5 times normal upper limit; 7. Allergic to the drugs or other genetic engineering biological products from Escherichia coli; 8. Suffering from mental or neurological disorders; 9. Investigator think it is not suitable for recruiting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of III/IV neutropenia | 3 months | The incidence of III/IV neutropenia in each chemotherapy cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of FN | 3 months | Incidence of febrile neutropenia (FN) in each chemotherapy cycle |
| Proportion of chemotherapy dose adjustment | 3 months | Proportion of chemotherapy dose adjustment due to neutropenia |
Countries
China
Contacts
Primary ContactMei Shi, MD
Outcome results
None listed