advanced non-small-cell lung cancer without harboring sensitive EGFR mutations
Conditions
Interventions
chemotherapy
Sponsors
Department of Comprehensive Cancer Therapy, Shinshu Universituy School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients were eligible if they had histologically or cytologically proven unresectable locally advanced NSCLC (clinical stage 3 b with pleral effusion or stage 4, without a history of prior chemotherapy and radiotherapy. In addition, EGFR mutations were analyzed using the available tissue for diagnosis and patients without carrying EGFR mutations were enrolled in the study. Other criteria included the following: 1)age over20 and lessthan 75 years, 2) World Health Organization (WHO) performance status 0-2, 3) measurable disease and an estimated life expectancy over 3 months, 4) adequate bone marrow function (neutrophil count >2000/ul, hemoglobin 9 g/dl, platelets counts > 100,000/ul ), normal hepatic function (total bilirubin level < 1.5 times and AST < 2.5 times the upper normal limits), and renal function (creatinine <1.2 mg/dl, creatinine clearance > 45 ml/min), and partial oxygen tension over 60 torr.
Exclusion criteria
Exclusion criteria: 1) pulmonary fibrosis on chest radiograph, 2)active infection, 3) severe heart disease, 4) past history of hypersensitivity to drugs, 5) pleural or pericardial effusion that required drainage, 6) brain metastasis or 7) pregnancy. Patients with a concomitant active malignancy were also excluded. Other concomitant anticancer therapy or experimental drug administration of any type was not permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate, safety, overall survival, one-year-survial | — |
Countries
Japan
Contacts
Public ContactTomonobu Koizumi
Shinshu University School of Medicine First Department of Internal Medicine
Outcome results
None listed