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

  • STATUS
    Recruiting
  • End date
    Apr 21, 2022
  • participants needed
    780
  • sponsor
    Gustave Roussy, Cancer Campus, Grand Paris
Updated on 18 August 2021

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)

Details
Condition Low Risk Differentiated Thyroid Cancer
Treatment Follow Up, rhTSH stimulation, I131
Clinical Study IdentifierNCT01837745
SponsorGustave Roussy, Cancer Campus, Grand Paris
Last Modified on18 August 2021

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