Phase III Study of Monotherapy by Gemcitabine or Vinorelbine Comparing to Doublet by Carboplatin and Paclitaxel Among Elderly Patients With Stage IIIB/IV NSCLC (Obligatory Second-line by Erlotinib)
It thus seemed to us justified to compare a standard arm, the vinorelbine or the gemcitabine
(with the choice of the center) in monotherapy with an experimental arm, association
carboplatine + paclitaxel. To avoid skewing the results by the introduction of a second
line to the choice of the investigator, we chose to force it. It is thus the erlotinib
which in a recent test presented by the NCIC at the ASCO 2004 proved its effectiveness in
second or third line at the same time in term of response but more especially survival
compared to the purely palliative care.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
1-year
Yes
Elisabeth QUOIX, Pr
Principal Investigator
IFCT
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
IFCT-0501
NCT00298415
March 2006
December 2011
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