Secondary objectives
hypoparathyroidism, 8+/−2, dysphonia, paralysis
RECURRENCES, DISEASE, HYPOPARATHYROIDISM, REMISSION, METASTASES
To compare total thyroidectomy and radioactive iodine (Thyroglobulin levels after surgery alone (usTg/T4) measured while on T4 treatment, 8+/−2 weeks postoperatively, before stimulation and administration of radioactive iodinePercent of patients in complete remission (excellent response) at 3 and 5 years after randomization, as defined by a normal neck ultrasound and usTg/LT4 ≤ 0.2 ng/m. The endpoint of 5 years reflects the data from a prospective multicenter study of 715 patients reporting that 81% of recurrences occurred within 5 years,[Percent of patients at 1, 3, and 5 years after randomization with structural incomplete response in the neck defined by a malignant lesion in the neck detected by ultrasound and confirmed by cytology (and/or Tg in the needle washout fluid >10ng/ml). Cytology will be mandatory for suspicious lesions measuring 8mm or more in the smallest diameter; lesions with suspicious features on ultrasound but measuring <8 mm may undergo cytology at the discretion of the center’s principal investigators.Percent of patients at 1, 3, and 5 years after randomization with biological incomplete response defined by a normal neck ultrasound and absence of disease detected on other conventional or metabolic imaging (Percent of patients at 1, 3, and 5 years after randomization with an indeterminate response defined by a suspicious lesion on neck ultrasound without cytological proof of disease and/or detection of TgAbPercent of patients at 1, 3, and 5 years after randomization with diagnosis of distant metastases on metabolic imaging (Percent of patients at 1, 3, and 5 years after randomization having undergone further treatment (surgery or 2nd therapeutic administration of At 1 year: percent of patients with persistent hypoparathyroidism with supplementation and/or persistent vocal fold paralysis; subjective dysphonia (Voice Handicap Index)[Cost-utility analysis.