How to treat the relapse of NSCLC after surgery and chemotherapy? IFTC 0702 randomized phase III study
Fiche publication
Date publication
janvier 2008
Auteurs
Membres identifiés du Cancéropôle Est :
Dr DEBIEUVRE Didier
Tous les auteurs :
Moro-Sibilot D, Barlesi F, Timsit JF, Debieuvre D, Fournel P, Gervais R, Mazieres J, Milleron B, Morin F, Perol M, Soria JC, Souquet PJ, Vergnenegre A, Zalcman G
Lien Pubmed
Résumé
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.
Référence
Rev Mal Respir. 2008 Jan;25(1):91-6.