Non-small Cell Lung Cancer
Conditions
Keywords
operable and resectable stage IIIA (T1-3, N2) NSCLC
Brief summary
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.
Detailed description
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.
Interventions
DRUGCisplatin-Gemzar
DRUGCisplatin-Navelbine-Radiotherapy
DRUGCarboplatin-Taxol-Radiotherapy
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Operable and resectable stage IIIA (T1-3, N2) NSCLC * World Health Organization (WHO) performance status of 1 or less
Exclusion criteria
* Severe cardiac, respiratory, renal or hepatic failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities) | at week 22 |
Countries
France
Outcome results
None listed