Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer

Randomized Phase II Trial Using Concomitant Chemoradiation Plus Induction or Consolidation Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer Patients

Randomized study in 2 arms, without any masking in patients with non small cell lung cancer, histologically or cytologically confirmed, not liable to surgery, stage IIIB or IIIA, according to the TNM classification of the American Joint Committee for cancer. In one arm will be administered concomitant radiotherapy and carboplatin-docetaxel-gemcitabine followed by docetaxel and, in the other arm will be administered docetaxel-gemcitabine followed by concurrent radiotherapy with carboplatin-docetaxel

Inclusion Criteria:

• Unresectable stage IIIA or B NSCLC patients
• WHO PS 0 or 1
• Weight loss < 5 % within the last 3 months
• At least one measurable lesion
• Planning CT scan previous to randomization
• Written informed consent

Exclusion Criteria:

• Malignant effusion, supraclavicular node or SVCS
• PTV > 2000 cm3
• V20 > 35%
• FEV1 and DLCO both < 30% or 1 liter at study entry