Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer.
The standard treatment for advanced small cell lung cancer (SCLC) is combination
chemotherapy of cisplatin or carboplatin with etoposide. Standard fixed doses of this
combination have been based on calculating a patient's body surface area. This method of
dose calculation has been shown to be poorly correlated with the activity of many
chemotherapy drugs, and some patients do not obtain adequate levels of the drug in their
circulation. Recent reports suggest that patients who have a very high tolerability to
chemotherapy (without significant toxicity), are at risk for having less effectiveness of
the therapy. This study will compare fixed doses of standard chemotherapy with a new
strategy of the same chemotherapy with doses that will be adjusted according to the toxicity
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
after 3 and 6 cycles of chemotherapy
Cesare Gridelli, M.D.
S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
Italy: Ethics Committee