Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer

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

The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.

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