A Phase III Randomized Study Comparing A Chemotherapy With Cisplatin And Etoposide To A Etoposide Regimen Without Cisplatin For Patients With Extensive Small-Cell Lung Cancer
Inclusion Criteria:
- Histological or cytological diagnosis of small-cell lung cancer
- Extensive disease (i.e. a disease with distant metastases or that cannot be included
in a single irradiation field incorporating primary tumour, mediastinum and
supraclavicular lymph node(s))
- 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, radiotherapy or surgery
- Performance status < 60 on the Karnofsky scale
- A history of prior malignant tumor, except non-melanoma skin cancer or in situ
carcinoma of the cervix or a cured cancer (defined as a disease-free interval > 5
years)
- White blood cells < 4000/mm3
- Platelets < 100000/mm3
- Serum bilirubin > 1.5 mg/100 ml
- Serum creatinine > 1.3 mg/100 ml and creatinine clearance <60 ml/min
- Recent myocardial infarction (less than 3 months prior to date of diagnosis)
- Congestive cardiac failure or cardiac arrhythmia uncontrolled by medical treatment
- Uncontrolled infectious disease
- Serious medical or psychological factors which may prevent adherence to the treatment
schedule