Cancer: Non small cell lung cancer Cancer Malignant neoplasm of bronchus and lung
Conditions
Interventions
Randomised, phase III, comparative trial.
Sponsors
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. NHS patients with pathologically confirmed NSCLC, stage IIIa, IIIb, or IV 2. ineligible for curative radical radiotherapy or surgery after discussion in a multidisciplinary team setting comprised of at least a chest physician, a surgeon, and an oncologist 3. no previous chemotherapy 4. age older than 18 years 5. life expectancy of at least 12 weeks 6. adequate bone marrow reserve (leukocyte count > 3 × 10^9/L, platelet count > 100 × 10^9/L, and hemoglobin > 100 g/dL) 7. creatinine clearance > 60 mL/minute 8. adequate birth-control measures
Exclusion criteria
Exclusion criteria: 1. active infection 2. bony disease as the only measurable disease 3. prior radiotherapy to the sole site of assessable disease 4. inadequate renal or hepatic function 5. serious comorbidity 6. other malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) 7. peripheral neuropathy Grade > 2 8. significant neurologic or psychiatric disorder 9. symptomatic brain metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. time to progression 2. response rates 3. evaluation of toxicity 4. disease-related symptoms 5. World Health Organization performance status 6. quality of life | — |
Countries
United Kingdom
Outcome results
None listed