Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study
18 Years
70 Years
Both
Non-Small Cell Lung Cancer
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)
Outcome Time Frame:
at week 22
Principal Investigator
Francoise Mornex, Pr
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospices Civils de Lyon
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
IFCT-0101
NCT ID:
NCT00198367
Start Date:
January 2003
Completion Date:
December 2007
Related Keywords:
- Non-Small Cell Lung Cancer
- operable and resectable stage IIIA (T1-3, N2) NSCLC
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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