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A randomized double-blind multicenter phase III study of Pegylated Human G-CSFin patients receiving myelosuppressive chemotherapy

Blinded,Randomized,Multicenter phase III Study to evaluate single administration PEG-rhG-CSF100ug/kg or 6mg fixed-dose once per cycle versus daily rhG-CSFas an adjunct to chemotherapy in patients with breast cancer or NSLC

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002980
Enrollment
Unknown
Registered
2013-01-06
Start date
2011-12-28
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Chemotherapy-induced neutropenia

Interventions

Group 1:GCSF 5ug/kg
Group 2:PEG-GCSF100ug/kg
Group 3:PEG-GCSF 6mg

Sponsors

Cancer Hospital of Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Histologically and/or cytologically confirmed diagnosis of breast cancer suit for TAC/TA chemotherapy regimen or non-small cell lung cancer Patients suit for docetaxel/Taxoland Carboplatin chemotherapy regimen; 2. Eastern Cooperative Oncology Group performance status 3 months; 4. Patients aged 18 to 70 years; 5. Absolute neutrophil count >=1.5*10^9/l; platelet count >=100*10^9/l; 6. ECG showed no abnormalities, no significant cardiac dysfunction; 7. Bilirubin and/or aspartate transaminase and/or alanine transaminase >=1.5*upper limit of normal (<=2.5*upper limit of normalif liver metastases are present); 8. renal function: Cr <=1.25 times the upper limit of normal, BUN <=1.25 times the upper limit of normal; 9. Subjects voluntarily participated in the clinical trials, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects received radiotherapy within 12 weeks before participated this clinical trail(excluding local radiotherapy for bone metastases); 2. History of Receiving hematopoietic stem cell transplant or bone marrow transplant; 3. Patients is participating in other clinical trials; 4. Patients had uncontrolled infection currently, Body temperature >=38 degree C; 5. Prior treatment with PEG-rhG-CSF; 6. Prior chemotherapy Within the late 4 months; 7. subjects with bone marrow metastasis; 8. subjects with disturbance of consciousness of brain metastasis; 9. Serious chronic diseases of heart, kidney, liver and other vital organs ; 10. uncontrolled diabetes; 11. subjects of pregnancy or Lactation; 12. Suspected history of hypersensitivity to Escherichia coli–derived products; 13. History of drug abuse or alcohol abuse; 14. subjects with severe mental or nervous system disorders, affecting informed consent and/or adverse events expression or observation.

Design outcomes

Primary

MeasureTime frame
Duration of grade 3 or 4 neutropenia;

Contacts

Public ContactBinghe.Xu
bhxu@hotmail.com.cn+86 010-87788826

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026