ECOG PS2 patients with advanced non-small cell lung cancer
Conditions
Interventions
Carboplatin and paclitaxel
Gemcitabine and vinorelbine
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically proven NSCLC with no prior chemotherapy 2. Stage IIIB with malignant pleural or pericardial effusion, stage IV, or recurrent disease after prior surgery or radiotherapy 3. Measurable or evaluable disease; 4. ECOG performance status of 2 5. Life expectancy ≥3 months 6. Age ≥18 years 7. Adequate baseline organ function: Neutrophile ≥1,500/mm3; platelet count ≥100,000/mm3; aspartate aminotransferase and alanine aminotransferase ≤5 times of the institutional upper limit; total bilirubin ≤1.5 mg/dl; serum creatinine ≤1.5 mg/dl or 24-hour creatinine clearance ≥60 ml/min 8. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Prior radiotherapy to evaluable disease unless subsequent progression at that site 2. Prior brain metastases if not clinically stable after surgery and/or radiotherapy 3. Uncontrolled hypertension, unstable angina pectoris, myocardial infarction <6 months before enrollment or congestive heart failure 4. Active concomitant malignancy requiring treatment. 5. Uncontrolled serious active infection 6. Pre-existing grade 2 neuropathy 7. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, time to progression, safety,QOL | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed