Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?

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)

NCT Number	NCT01837745
Lead Sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Conditions	Low Risk Differentiated Thyroid Cancer
Enrollment	776 participants
Start Date	2013-05-13
Primary Completion	2022-04-01 (estimated)
Study Completion	2030-01-01 (estimated)
Updated on ClinicalTrials.gov	2023-05-17