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Brief Title: Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
Official Title: Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
Study ID: NCT01837745
Brief Summary: Open-label randomized phase III trial, using a non-inferiority comparison design. After randomization,patients will receive either post-operative radioiodine ablation with an activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation group) or be followed-up (without postoperative radioiodine ablation) (follow-up group). The objective is to assess the non-inferiority of the proportion of patients without tumor-related event evaluated at three years after randomisation in the absence of radioiodine ablation (follow-up group) compared to the ablation group, in patients with low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph node dissection (pT1am N0 or Nx, pT1b N0 or Nx)
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institut Gustave Roussy, Villejuif, Val De Marne, France