Trial Information
A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) on the Incidence of Neutropenia in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) Treated With Myelosuppressive Chemotherapy
Inclusion Criteria:
- Investigator diagnosis of staged III or IV NSCLC
- Age 18 to 70 years
- ECOG performance status ≤ 1
- Chemotherapy naïve
- Body weight ≥ 45kg
- Hemoglobin ≥ 100g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 ×
109/L; platelet count ≥ 100 × 109/L
- Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine
≤1.5×ULN; total bilirubin ≤1.5×ULN
Exclusion Criteria:
- History of systematic chemotherapy or radical radiation therapy
- Prior bone marrow or stem cell transplantation
- Received systemic antibiotics treatment within 72 h of chemotherapy
- Pregnancy or lactation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Rate of grade 3/4 neutropenia in cycle 1
Outcome Description:
the rate of ANC lower than 1.0 × 109/L
Outcome Time Frame:
21 days
Safety Issue:
No
Principal Investigator
Caicun Zhou
Investigator Role:
Principal Investigator
Investigator Affiliation:
Shanghai Pulmonary Hospital, Shanghai, China
Authority:
China: Food and Drug Administration
Study ID:
HHPG-19K -III-02
NCT ID:
NCT01560195
Start Date:
April 2012
Completion Date:
Related Keywords:
- NSCLC
- Neutropenia
- Febrile Neutropenia
- neutropenia
- febrile neutropenia
- chemotherapy
- Carcinoma, Non-Small-Cell Lung
- Fever
- Lung Neoplasms
- Neutropenia