A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer
Inclusion Criteria:
- Histological or cytological diagnosis of non-small cell lung cancer
- Advanced (unresectable or functionally inoperable) stage III or stage IV disease
- Availability for participating in the detailed follow-up of the protocol
- Presence of an evaluable or measurable lesion
- Informed consent
Exclusion Criteria:
- Prior treatment with chemotherapy
- Operable patient with resectable tumour
- Performance status < 60 on the Karnofsky scale
- A history of prior malignant tumour, except non-melanoma skin cancer or in situ
carcinoma of the cervix and cured malignant tumour (more than 5-year disease free
interval)
- Polynuclear cells < 2,000/mm³
- Platelet cells < 100,000/mm³
- Serum bilirubin >1.5 mg/100 ml
- Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min
- Perception hypoacousia
- Peripheral neuropathy
- Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- Congestive cardiac failure requiring medical therapy or uncontrolled cardiac
arrhythmia
- Uncontrolled infectious disease
- Serious medical or psychological factors which may prevent adherence to the treatment
schedule