A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile, and the progression-free survival in both arms of treatment (3D Radiotherapy versus 3D Radiotherapy + erlotinib) in patients who have not received previous chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Erlotinib (Tarceva®), 150mg/day p.o during 6 months.
Hospital Clínic i Provincial de Barcelona
Barcelona, Barcelona, Spain
RECRUITINGHospital Puerta de Hierro
Madrid, Madrid, Spain
RECRUITINGFundación Jimenez Diaz
Madrid, Madrid, Spain
To determinate the viability and toxicity profile of Erlotinib + 3D Radiotherapy treatment (% of patients presenting toxicity 3-4 during the treatment).
The progression-free survival.
1-year survival.
Overall survival.
Objective response rate, according to RECIST criteria.
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Hospital de Navarra
Pamplona, Navarre, Spain
RECRUITINGHospital de Donostia
Donostia / San Sebastian, San Sebastian, Spain
RECRUITING