Stage IIIb/IV NSCLC
Conditions
Interventions
Patients in group one will receive an infusion of gemcitabine on days 1 and 8. They will also receive an infusion of carboplatin on day 1.
Patients in group two will receive infusions of gemcit
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients enrolled in this trial had histologically or cytologically confirmed stage IIIb or IV NSCLC. Patients with stage IIIb disease who were not candidates for thoracic radiation and those with stage IV disease were eligible, if they had not received previous chemotherapy, had measurable disease, and had a life expectancy of at least 3 months. Patients who had received previous radiotherapy were included, if they had assessable disease outside of the radiation field. Patients with post operative recurrence were also allowed. Additional entry criteria were age 20-74 years, performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, and adequate bone marrow (leukocyte count > 3,500/mL, neutrophil count > 2,000/mL, hemoglobin concentration > 10.0 g/dL, platelet count > 100,000 /mL), kidney (creatinine 60 torr) functions.
Exclusion criteria
Exclusion criteria: Patients were excluded if they had any active concomitant malignancies, symptomatic brain metastases, prior radiotherapy to the sole site of measurable disease, past history of severe allergic reactions to drugs, interstitial pneumonia identified by chest X-ray, liver cirrhosis, superior vena cava syndrome, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure, uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year survival rate | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed