This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment chemotherapy (gemcitabine, paclitaxel, vinorelbine)
Phase phase 2
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)
time frame: at week 22

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.