Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)
Recruitment status was Active, not recruiting
Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests of exclusive CT, or in noncomparative tests of RT-CT.
Non-Small Cell Lung Cancer
Drug: Chemotherapy (Gemcitabine, Paclitaxel, Vinorelbine)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study|
- percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities) [ Time Frame: at week 22 ]
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||December 2007|
These results justify the choice of the study design currently suggested, testing the preoperative feasibility
- chemotherapy: cisplatin-Gemzar (arm A) or
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198367
|Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie|
|Principal Investigator:||Francoise Mornex, Pr||Hospices Civils de Lyon|
|Principal Investigator:||Bernard Milleron, Dr||IFCT|