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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
776
Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment
An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH.
* 10 (+/- 2 months) after randomization: a neck ultrasound and a serum Tg measurement after rhTSH or LT4 stimulation * 2 years (+/- 2 months) after randomization: a serum Tg measurement under LT4 treatment (Tg/LT4) * 3 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 * 4 years (+/- 2 months) after randomization: a serum Tg/LT4 * 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 * 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 * 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4 * 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
Institut Gustave Roussy
Villejuif, Val De Marne, France
Rate of patient without event at 3 years following randomization
Time frame: assessed up to 3 years
Lachrymal and Salivary Glands Toxicities
Time frame: Assessed up at baseline, 2 months, 10 months and 3 years after randomization
Patient's quality of life, anxiety and fear of recurrence
Time frame: at inclusion, 2 months after inclusion, 10 months and 3 years after randomization
Rate of patients without event
Time frame: at 5 years following randomization
Rate of events adjusted on the initial lymph node status
Time frame: at 3 and 5 years following randomization
Recurrence rate (histologically proven)
Time frame: at 3 years following randomization and then at 5 years
Rate of cure after an event
Time frame: at 5 years after randomization
Cost of treatment and follow-up
Time frame: at 3 years after randomization
Rate of events adjusted on tumoral molecular characterization
Time frame: 3 and 5 years after randomization
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