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document
[ How to treat the relapse of NSCLC after surgery and chemotherapy ? IFTC 0702 randomized phase III study ] . BACKGROUND As chemotherapy gains wider acceptance for the treatment of earlier stages of NSCLC , particularly in the adjuvant and neoadjuvant setting , physicians face a growing population of high performance status patients who have relapsed after their first-line chemotherapy . The type of second-line chemotherapy after initial adjuvant or neoadjuvant treatment with a platinum-based regimen remains largely undefined . The current study has been designed to compare the classical mono chemotherapy docetaxel with a docetaxel cisplatin doublet . METHODS Patients will be randomized in 2 arms . Arm : docetaxel cisplatin ( cycles repeated every 21 days ) , 4 cycles followed by 2 cycles of docetaxel alone in case of objective response or stabilisation . Arm B : docetaxel alone ( cycles repeated every 21 days ) , 4 cycles followed by 2 cycles of docetaxel alone in case of objective response or stabilisation . EXPECTED RESULTS 300 patients will be randomized with a statistical hypothesis of a progression free survival of 3 months in the control arm and of 4.5 months in the experimental arm .
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Intervention_Physical
second-line chemotherapy
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Intervention_Pharmacological
platinum-based regimen
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Intervention_Pharmacological
mono chemotherapy docetaxel
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Intervention_Pharmacological
docetaxel cisplatin doublet
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Intervention_Pharmacological
docetaxel cisplatin
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Intervention_Pharmacological
docetaxel alone
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Outcome_Physical
relapse of NSCLC
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Outcome_Mortality
progression free survival