Active — Not RecruitingPhase 3

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

France776 participantsStarted 2013-05-13

Plain-language 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)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients with differentiated thyroid cancer (papillary, follicular or with Hurthle cells) in the absence of aggressive histological subtypes (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing or with an anaplastic component)
✓. Patients having undergone a total thyroidectomy with complete (R0) tumor resection, with or without lymph node neck dissection
✓. Total thyroidectomy performed 2 to 5 months before inclusion
✓. Patients with low risk of recurrence: pT1amN0 or pT1amNx with a sum of the size of the lesions above 1 cm and equal to or less than 2 cm, or pT1bN0 or pT1bNx (TNM 2010 classification).
✓. Post-operative neck ultrasound (performed 2 to 5 months after surgery) showing the absence of abnormalities in the lateral lymph node compartments, or if abnormalities, no lymph nodes with abnormal cytology and/or thyroglobulin concentration in the aspirate fluid \> 10 ng/mL
✓. Age \>=18 years
✓. Performance status of 0 or 1
✓. Patients who signed the informed consent

Exclusion criteria

What they're measuring

Rate of patient without event at 3 years following randomization

Timeframe: assessed up to 3 years

Trial details

NCT IDNCT01837745

SponsorGustave Roussy, Cancer Campus, Grand Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-01

View on ClinicalTrials.gov More Low Risk Differentiated Thyroid Cancer trials