Docetaxel in Non Small Cell Lung Cancer (NSCLC)

A Phase II, Randomized Study With Docetaxel-gemcitabine Followed by Radiotherapy vs Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) Followed by Docetaxel-gemcitabine Versus Docetaxel-gemcitabine Followed by Concomitant Treatment (Radiotherapy and Carboplatine-docetaxel) in Stage III NSCLC

Primary objective:

• To classify the 2 study groups, according to the tumoral response.

Secondary objectives:

• To evaluate the percentage of focused control per year.
• To calculate the time until progression.
• To evaluate the safety profile.

Inclusion Criteria:

• Non small cell lung cancer confirmed by histology or by cytology.
• IIIB stage, except if existing pleural discharge, upper cava vein syndrome or supraclavicular affectation
• General stage 0-1 at the ECOG scale
• Loss of weight less than 5% in the 3 previous months from diagnose.
• Pulmonary function and gasometry results: FEV1 > 30% or 1 l, DLCO (diffusing capacity of the lung for carbon monoxide) > 30%, PCO2 < 45 mmHg and PO2 > 60 mmHg.
• Normal medullar function (hemoglobin > 11 g/dl, total WBC > 1,5 x 10^9/l, platelets > 100 x 10^9/l)
• Appropriate renal and hepatic functions
• CTScan
• Anticonceptive method
• Available laboratory test (maximum 1 month before)

Exclusion criteria:

• Pleural discharge, upper cava vein syndrome or supraclavicular affectation.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.