Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
Condition(s) studied
Investigational drug(s) / intervention(s)
rhTSH stimulation: Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment
I131: An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH.
Follow up: * 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
Study 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)
Eligibility
Primary outcome measure(s)
- Rate of patient without event at 3 years following randomization — assessed up to 3 years
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Institut Gustave Roussy | Villejuif | Val De Marne |
More Gustave Roussy, Cancer Campus, Grand Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT01837745 on ClinicalTrials.gov ↗ ← All trials in France