Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study
These results justify the choice of the study design currently suggested, testing the
preoperative feasibility
1. chemotherapy: cisplatin-Gemzar (arm A) or
2. chemoradiotherapy: cisplatin-navelbine-radiotherapy (arm B) or
Carboplatin-Taxol-radiotherapy (arm C).
The results obtained, in terms of feasibility and toxicity, will make it possible to select
the optimal diagrams for a phase III study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)
at week 22
Francoise Mornex, Pr
Principal Investigator
Hospices Civils de Lyon
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
IFCT-0101
NCT00198367
January 2003
December 2007
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