Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
Status:
Active, not recruiting
Trial end date:
2022-05-12
Target enrollment:
Participant gender:
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)