Ensayos clínicos

Inclusion Criteria:

1. Documentation of Disease (American Joint Committee on Cancer Version 7)
   • Histologically or cytologically documented non-small cell lung cancer (NSCLC)
   • Stage: IIIA or IIIB NSCLC. Patients who present with N2 or N3 disease and an undetectable primary tumor are also eligible.
   • Tumor Site: Thoracic disease without supraclavicular or contralateral hilar involvement
   • Pleural Effusion: When pleural fluid is visible on both CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.

   Exudative pleural effusions are excluded regardless of cytology. Patients with effusions that are minimal (i.e. not visible on chest x-ray) too small to safely tap are eligible.

2. Prior Treatment
   • No prior radiotherapy or chemotherapy for NSCLC
   • No prior mediastinal or thoracic radiotherapy
   • Patients with complete surgical resection of disease are not eligible, however, patients with surgical resection and measurable gross residual disease present on imaging are considered eligible.
3. Patients must have Measurable Disease
   • Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT scan.
   • Patients with non-measurable disease are not eligible
   • All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions.
   • Lesions that are considered non-measurable include the following:
     • Bone lesions
     • Leptomeningeal disease
     • Ascites
     • Pleural/pericardial effusion
     • Inflammatory breast disease
     • Lymphangitis cutis/pulmonis
     • Abdominal masses that are not confirmed and followed by imaging techniques
     • Cystic lesions
4. Age ≥ 18 years
5. ECOG Performance Status 0-1
6. No patients that are known to be pregnant or nursing.
7. Required Initial Laboratory Values:
   • Granulocytes ≥ 1,500/μl
   • Platelet count ≥ 100,000/μl
   • Bilirubin ≤ 1.5 x ULN
   • AST (SGOT) ≤ 2.0 x ULN
   • Serum Creatinine ≤ 1.5 x ULN or
   • Calculated Creatinine Clearance ≥ 70 ml/min
   • FEV-1 ≥ 1.2 liters/second or 50% predicted