Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer (PET START Trial)

Inclusion Criteria:

• Histological or cytological evidence of NSCLC. Must have documented pathology report with histology indicated (e.g. squamous, adenocarcinoma, large cell, NSCLC not otherwise specified).
• Stage III (mediastinal node positive) NSCLC based on conventional staging (e.g. computed tomography [CT] scan of chest and upper abdomen, CT or magnetic resonance imaging [MRI] of brain, bone scan).
• Suitable for combined modality (chemotherapy and radiation) therapy or radical radiation therapy or trimodality therapy (chemotherapy, radiation and surgery).

Exclusion Criteria:

• Stage IV NSCLC (by conventional staging).
• Small cell lung cancer.
• Poor performance status Eastern Cooperative Oncology Group (ECOG) 3-4.
• Poor pulmonary function precluding radical radiation therapy (Adequate pulmonary reserve for radical radiation therapy. Pulmonary function tests should have forced expiratory volume in 1 second (FEV1) > 1.0 liter or > 40% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) > 45% and/or predicted contralateral FEV1 > 800 cc based on quantitative ventilation perfusion lung scan).
• Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease).
• Insulin dependent diabetic where requirements for PET imaging may be problematic.
• Unable to lie supine for at least 30 minutes in radiation treatment position for imaging with PET.
• Failure to provide informed consent.
• Previous PET scan relating to recent cancer diagnosis prior to entry into study.
• Pregnant or lactating females.
• Prior thoracic radiation.
• Prior malignancy within 3 years from randomization (except nonmelanotic skin cancer or carcinoma in situ of the cervix).
• Administered more than two cycles of chemotherapy prior to radical radiation therapy or concurrent chemoradiation (as part of induction or sequential chemotherapy prior to randomization) for the current malignancy.