Non-small cell lung cancer
Conditions
Interventions
pegfilgrastim non-use group(daily use of G-CSF is permitted at the time of grade 4 neutropenia or febrile neutropenia)
pegfilgrastim use group
Sponsors
Kagawa Universit, Department of Internal Medicine, Hematology, Rheumatology and Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically proved non-small cell lung cancer 2)Relapse or a case considered no surgical indication 3)ECOG Performance Status 0-2 4)Scheduled to be the combination therapy of docetaxel and ramucirumab 5)Meets the following criteria within 7days before enrollment hemoglobin: >=9 g/dL absolute neutrophil: >=1500/mm3 white blood cell count: >=3000/mm3 platelet count: >=100,000/mm3 AST and ALT: <=2.5 X ULN total bilirubin: <=1.5mg/dL PaO2: >=60mmHg or SpO2: >=90%(Room air) 6)Written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1)Patients must not have any allergy with G-CSF in the past 2)Pregnant or nursing women 3)Tumor invasive to the chest large blood vessel, Cavity in lung tumor 4)Serious complications (heart failure, celebrovascular disorder, or active peptic ulcer etc) 5)History of hemoptysis with 2.5mL or more and Continued bloody phlegm 6)Evidence of bleeding diathesis or coagulopathy 7)Uncontrolled mental disease 8)Uncontrolled hypertension 9)Uncontrolled diabetes 10)Uncontrolled infectious disease 11)Patients with myelodysplastic syndrome or aplastic anemia 12)Double cancer in need of treatment 13)Planned radiation therapy 14)Patients were judged unqualified for this study by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of febrile neutropenia during the first cycle of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Lowest white blood cell count, Lowest neutrophilic count, Days to febrile neutropenia, Days to a neutropenia to recovery, Adverse events, Severe adverse events, Association with the previously treated regimen | — |
Countries
Japan
Contacts
Public ContactNaoki Watanabe
Kagawa University Department of Internal Medicine, Hematology, Rheumatology and Respiratory Medicine
Outcome results
None listed