The Impact of Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer: A Prospective Randomized Clinical Trial (PET START Trial)
- Histological or cytological evidence of NSCLC. Must have documented pathology report
with histology indicated (e.g. squamous, adenocarcinoma, large cell, NSCLC not
- 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).
- 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.