- Definitive clinical or radiologic evidence of metastatic disease; required imaging studies must have been performed within 28 days prior to randomization; Note: Distant clinical staging to exclude patients with overt metastatic disease is determined by CT scan with IV contrast (chest/abdomen/pelvis), with or without PET scan (preferred); MRI of the abdomen and pelvis and a chest x-ray (posterioranterior [PA] and lateral) is acceptable; (it is recommended that the same imaging tests that are performed before randomization be used at follow-up time points)