Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)
This trial is active, not recruiting.
|Condition||non-small cell lung cancer|
|Treatment||chemotherapy (gemcitabine, paclitaxel, vinorelbine)|
|Sponsor||Hospices Civils de Lyon|
|Start date||January 2003|
|End date||December 2007|
|Trial size||120 participants|
|Trial identifier||NCT00198367, IFCT-0101|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)
time frame: at week 22
Male or female participants from 18 years up to 70 years old.
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
|Official title||Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study|
|Principal investigator||Francoise Mornex, Pr|
|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.|
Call for more information