Phase III Study of Monotherapy by Gemcitabine or Vinorelbine Comparing to Doublet by Carboplatin and Paclitaxel Among Elderly Patients With Stage IIIB/IV NSCLC (Obligatory Second-line by Erlotinib)
70 Years
89 Years
Both
NSCLC
Trial Information
Phase III Study of Monotherapy by Gemcitabine or Vinorelbine Comparing to Doublet by Carboplatin and Paclitaxel Among Elderly Patients With Stage IIIB/IV NSCLC (Obligatory Second-line by Erlotinib)
It thus seemed to us justified to compare a standard arm, the vinorelbine or the gemcitabine
(with the choice of the center) in monotherapy with an experimental arm, association
carboplatine + paclitaxel. To avoid skewing the results by the introduction of a second
line to the choice of the investigator, we chose to force it. It is thus the erlotinib
which in a recent test presented by the NCIC at the ASCO 2004 proved its effectiveness in
second or third line at the same time in term of response but more especially survival
compared to the purely palliative care.
Inclusion Criteria:
- Pathologically / cytologically proven NSCLC stage IIIB or IV
- age >= 70 years old and < 90 years old
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
1-year
Safety Issue:
Yes
Principal Investigator
Elisabeth QUOIX, Pr
Investigator Role:
Principal Investigator
Investigator Affiliation:
IFCT
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
IFCT-0501
NCT ID:
NCT00298415
Start Date:
March 2006
Completion Date:
December 2011
Related Keywords:
- NSCLC
- 2-years survival
- Carcinoma, Non-Small-Cell Lung
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