elderly patients with stage IIIB/IV non-small cell lung cancer except for squamous cell carcinoma
Conditions
Interventions
Sponsors
Yamaguchi Thoracic Oncology Group (YTOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically confirmed non-small cell lung cancer except for squamous cell carcinoma 2) chemotherapy naive 3) clinical stage IIIB/IV or relapsed case 4) with measurable lesions 5) written informed consent after the explanation of the content of the examination 6) more than 75-years old 7) PS (ECOG) 0-2 8) estimated survival is more than 3 months 9) Adequate organ functions Neutrophil: => 1500 /mm3 Platelet: => 100,000 /mm3 Hemoglobin concentration: => 9.0 g/dl Total bilirubin: <= 1.5 mg/dl AST or ALT: <= 100IU/l Cr: <= 1.2 mg/dl proteinuria: <= 1+
Exclusion criteria
Exclusion criteria: 1) transfusion or G-CSF within 2weeks prior to enrollment 2) history of severe drug allergy 3) history of active double cancer within 5 years 4) history of active severe infections 5) severe cardiac disease 6) history of thromboembolism or severe pulmonary disease 7) history of GI bleeding, ileus, GI ulceration 8) history of hemoptysis (more than 2.5mL) 9) massive pleural or pericardial effusion, ascites 10) active brain metastases 11) history of mental disorder, central nervous system damage, cerebrovascular disease 12) Uncontrollable hypertension or diabetes mellitus 13)Uncontrollable diarrhea 14)Wound of unrecovery 15)bleeding diathesis or receiving anticoagulant drug(except Aspirin under 324mg/day) 16)Evaluated to be ineligible by a physician for other reasons
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| disease control rate, progression free survival, overall survival, safety, evaluavte effectiveness by tumor maker(CYFRA) | — |
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Countries
Japan
Contacts
Public ContactKeisuke Aoe
Yamaguchi-Ube Medical Center Department of Medical Oncology
Outcome results
None listed