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ACTIVE NOT RECRUITING
NCT01837745
PHASE3

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

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

776

Start Date

2013-05-13

Completion Date

2030-01-01

Last Updated

2023-05-17

Healthy Volunteers

No

Interventions

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

Locations (1)

Institut Gustave Roussy

Villejuif, Val De Marne, France