Stage IIIB or IV
Conditions
Interventions
None listed
Sponsors
Shinjuku Thoracic Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically proven non-small and non-squamous cell lung cancer 2.Stage IIIB/IV by UICC ver.7 or recurrence after surgical treatment 3.Tolerable for chemotherapy of non-small cell lung cancer 4.Eastern Cooperative Oncology Group performance status of 0-2 5.Duration requested after below treatment; Palliative irradiation; >=2 weeks Surgical operation; >= 4 weeks Chest drainage; >= 2 weeks Incisional biopsy, Implant of port, Treatment for injury; >=2 weeks Aspiration biopsy; >= one week 6.Adequate organ function Leukocyte count 3,000-12,000/mm^3 Neutrocyte count; >=1,500/mm^3 Platelet count; >= 100,000/mm^3 Hemoglobin concentration; >= 9.0 g/dL AST and ALT; less than 2.5 times of the institutional upper limits of normal level Total bilirubin level <=1.5 mg/dL Creatinine clearance; >= 45mL/min SpO2; >= 90% Proteinurea ; <=1+ or 2 g / 24hrs 7.Written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria included: 1.Patient with squamous cell lung cancer 2.Radiological evidence of tumor invading or abutting major blood vessels and evidence of brain metastases, even if previously treated. But eligible for disappeared or controlled brain metastases 3.Significant comorbid disease; active infection, arrhythmia, severe heart disease, elevated electrocardiogram abnormality, uncontrolled diabetes mellitus, other uncontrolled disease 4. A history of significant hemoptysis; >= 2.5 mL red blood per episode within 3 months before enrolment 5.A history of continuous hemoptysis over one week, or hemoptysis receiving oral or intravenous hemostatic drug 6. Uncontrolled hypertension 7. Perforation of gastrointestinal tract within one year 8. The operation has been scheduled for the examination period 9. A history of allergic reaction for the treatment drugs 10. Active concomitant malignancy 11. Pregnant or lactating women, couple wishing pregnant or no mind of prevent pregnancy 12. Other concominant medical condition deemed to inadequate for inclusion to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy (progression free survival) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Time to response, Individual side effect and efficacy, Landmark analysis | — |
Countries
Japan
Contacts
Public ContactYuichiro Takeda
National Center for Global health and Medicine Department of respiratory medicine
Outcome results
None listed