NCT01837745

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 776 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Low Risk Differentiated Thyroid Cancer

Interventions

Type	Name	Description
DRUG	rhTSH stimulation	Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment
DRUG	I131	An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH.
OTHER	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

Timeline

• Start date: 2013-05-13
• Primary completion: 2022-04-01
• Completion: 2030-01-01
• First posted: 2013-04-23
• Last updated: 2023-05-17

Locations

1 site across 1 country: France