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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhG-CSF | Experimental | PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy,with patients' weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight <45kg were given 3mg once per chemotherapy cycle. |
|
| rhG-CSF | Active Comparator | rhG-CSF was daily 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhG-CSF | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of III/IV neutropenia | The incidence of III/IV neutropenia in each chemotherapy cycle | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of FN | Incidence of febrile neutropenia (FN) in each chemotherapy cycle | 3 months |
| Proportion of chemotherapy dose adjustment | Proportion of chemotherapy dose adjustment due to neutropenia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Shi, MD | Contact | +86-29-84775425 | Shimei82@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mei Shi, MD | Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
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|
| rhG-CSF | Drug | 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. |
|
|
| 3 months |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |