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

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Institut Gustave Roussy, Villejuif, Val De Marne, France

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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