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[How to treat the relapse of NSCLC after surgery and chemotherapy? IFTC 0702 randomized phase III study]

Abstract : 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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https://www.hal.inserm.fr/inserm-00335220
Contributor : Aurélien Vesin <>
Submitted on : Tuesday, October 28, 2008 - 5:47:21 PM
Last modification on : Thursday, August 27, 2020 - 11:36:03 AM

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  • HAL Id : inserm-00335220, version 1
  • PUBMED : 18288059

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Denis Moro-Sibilot, Fabrice Barlesi, Jean-François Timsit, Didier Debieuvre, Pierre Fournel, et al.. [How to treat the relapse of NSCLC after surgery and chemotherapy? IFTC 0702 randomized phase III study]. Revue des Maladies Respiratoires, Elsevier Masson, 2008, 25 (1), pp.91-6. ⟨inserm-00335220⟩

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