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

Study acronym: ESTIMABL2
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Mar 31, 2020 to Apr 1, 2022
    • Study completion date: May 12, 2022 to Jan 1, 2030
    • Secondary endpoints: details revised at 1 of 8 entries
    v8
  2. Eligibility criteria shortened, about 15 words
    • Secondary endpoints revised (8)
    v7
  3. Trial status: Recruiting to Active, Not Recruitingv6 Show 5 more changesShow less
    • Enrollment target: estimated 780 to confirmed 776
    • Primary completion date changed from estimate of Apr 2020 to Mar 31, 2020
    • Study completion date: Apr 2022 to May 12, 2022
    • Start date: Apr 2013 to May 13, 2013
    • Site details revised
  4. Primary completion date: Oct 2018 to Apr 2020
    • Enrollment target: 750 to 780
    • Study completion date: Oct 2020 to Apr 2022
    v5
  5. Re-verified, no change to tracked fieldsv4
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  1. Primary completion date: Oct 2015 to Oct 2018
    • Eligibility criteria expanded, about 1 word
    v3
  2. Trial status: Active, Not Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary endpoint revised
    • Interventions: Administration of 1.1 GBq of I131 (Drug), Follow up (Other), rhTSH stimulation (Drug) to Follow up (Other), I131 (Drug), rhTSH stimulation (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: 3 to 8
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT01837745
Lead Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Conditions
(from sponsor)		 Low Risk Differentiated Thyroid Cancer
Enrollment 776 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov