Previously untreated elderly non-squamous non-small cell lung cancer
Conditions
Interventions
Pemetrexed
Pemetrexed plus bevacizumab
Sponsors
Lung Oncology Group in Kyushu, Japan (LOGIK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically confirmed diagnosis of NSqNSCLC; 2) no prior chemotherapy or molecular targeted therapy 3) stage IIIB or IV with no indication of radical radiotherapy, or recurrence after operation 4) no active overlapping cancer 5) age >=75 years 6) Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1 7) adequate organ function (leukocyte count >=4,000/mm3, hemoglobin level >=9 g/dl, platelet count >=100,000/mm3, ALT and AST levels <100 IU/L,serum bilirubin level =<1.5 mg/dl,serum creatinine level=<1.5 mg/dl,proteinurea =<1+ and PaO2 >=60 Torr (or SpO2 >=90) 8) evaluable lesion 9) informed consent 10) life expectancy greater than 3 months
Exclusion criteria
Exclusion criteria: 1) symptomatic brain metastasis 2) complications as follows: hemoptysis, arterial and venous thromboembolism, uncontrolled hypertension, perforation of the digestive tract/severe fistula/bronchoesophageal fistula, inflammation in abdominal cavity, congenital bleeding predisponency/abnormality of hemostasis, uncontrolled diabetes 3) operation within 28 days 4) planning of thoracic radiotherapy in bevacizumab therapy 5) symptomatic pericardial effusion 6) symptomatic SVC syndrome 7) interstitial pneumonia confirmed in chest X-ray 8) psychotic disease judged should not to participate the trial 9) other inadequacy cases judged by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response, Overall survival, Adverse effect, Cost effectiveness | — |
Countries
Japan
Contacts
Public ContactMinoru Fukuda
Japanese Red Cross Nagasaki Genbaku Hospital Department of Respiratory Diesease
Outcome results
None listed