Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)

Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease

Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.

Fase III, multicenter randomised trial comparing up to six cycles of carboplatin and etoposide with up to six cycles of topotecan and cisplatin in patients with extensive stage small cell lung cancer and PS 0-3

Inclusion Criteria:

• Histologically confirmed SCLC
• Extensive stage
• No prior chemotherapy
• WHO PS 0-3
• Adequate organ function (liver, kidney)
• Adequate hematology (bone marrow)
• Informed consent

Exclusion Criteria:

• PS 4
• Inadequate organ function
• Uncontrolled infection
• Concomitant major medical contraindications