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A randomized cross-over controlled trial for comparing efficacy and safety of PEG-rhG-CSF versus rhG-CSF in the prevention of chemotherapy-induced neutropenia in sarcoma patients with doxorubicin + isocyclophosphamide treatment

A randomized cross-over controlled trial for comparing efficacy and safety of PEG-rhG-CSF versus rhG-CSF in the prevention of chemotherapy-induced neutropenia in sarcoma patients with doxorubicin + isocyclophosphamide treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021945
Enrollment
Unknown
Registered
2019-03-17
Start date
2019-04-01
Completion date
Unknown
Last updated
2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sarcoma

Interventions

AOB group:cycle 1: PEG-rhG-CSF 100µg/kg, once
cycle 2: rhG-CSF 5µg/kg/d, daily up to ANC=2×10^9/L
BOA group:cycle 1: rhG-CSF 5µg/kg/d, daily up to ANC=2×10^9/L
cycle 2: PEG-rhG-CSF 100µg/kg, once.

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Histopathology diagnosed with sarcoma, and suitable for doxorubicin + isocyclophosphamide treatment; 2. Accept at least 2 cycles of chemotherapy; 3. Aged 18 to 65 years, expected survival time >6 months; KPS=70; 4. Normal bone marrow hematopoietic function: ANC=1.5×10^9/L, PLT=80×10^9/L, Hb=100g/L, without hemorrhagic tendency; 5. Before the start of the study, all patients have been fully understood the research and the must sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Obvious abnormalities in electrocardiogram or echocardiography; 2. Accumulation of doxorubicin >240mg/m2 or epirubicin >360mg/m2; 3. Liver function: ALT, TBIL, AST > 2.5 ULN; 4. Renal function: Cr>1.5ULN; 5. Allergy to the research drug or other genetically engineered products; 6. Suffering from mental or neurological disorders, can not cooperate; 7. Undergoing chemotherapy in 6 months before recruitment; 8. The investigator believes that the patient's condition is not suitable for this clinical study.

Design outcomes

Primary

MeasureTime frame
Incidence of grade 4 neutropenia [ Time Frame: 21 day ];The duration of grade 4 neutropenia [ Time Frame: 21 day ];

Countries

China

Contacts

Public ContactJing Chen

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

chenjingunion@163.com+86 15807183251

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026