The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
707
Cisplatin 50 mg/m² day 1 Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles every 3 weeks
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium
Pneumology department of CHU Lille
Lille, France
Hellenic Cancer Institute - St Savas Oncology Hospital
Athens, Greece
Medical Oncology Hospital de Sagunto
Valencia, Spain
Survival
Time frame: Survival will be dated from the first day of registration until death or last follow up
Response rate
Time frame: Every 3 courses of chemotherapy
Toxicity
Time frame: After each course of chemotherapy
Activity of second-line chemotherapy
Time frame: Every 3 courses of chemotherapy
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