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| ID | Type | Description | Link |
|---|---|---|---|
| 2012/1913 | Other Identifier | CSET number |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation group | Active Comparator |
|
|
| Follow up group | Experimental | Patients randomized in the follow up group neither received 131I nor rhTSH. Patients will undergo the same followup procedures as patients randomized to the ablation group, except that at 10 months after randomization, Tg will be measured under LT4 treatment and not after rhTSH stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhTSH stimulation | Drug | Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patient without event at 3 years following randomization | assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Lachrymal and Salivary Glands Toxicities | Assessed up at baseline, 2 months, 10 months and 3 years after randomization | |
| Patient's quality of life, anxiety and fear of recurrence | at inclusion, 2 months after inclusion, 10 months and 3 years after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Gustave Roussy | Villejuif | Val De Marne | 94805 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39586309 | Derived | Leboulleux S, Bournaud C, Chougnet CN, Lamartina L, Zerdoud S, Do Cao C, Catargi B, Dygai I, Kelly A, Barge ML, Vera P, Rusu D, Schneegans O, Roux J, Raymond P, Benisvy D, Eberle MC, Bidault S, Nascimento C, Bastie D, Giraudet AL, Bardet S, Le Moullec N, Roudaut N, Drui D, Godbert Y, Zalzali M, Drutel A, Morel O, Velayoudom FL, Al Ghuzlan A, Schlumberger M, Buffet C, Borget I. Thyroidectomy without radioiodine in patients with low-risk thyroid cancer: 5 years of follow-up of the prospective randomised ESTIMABL2 trial. Lancet Diabetes Endocrinol. 2025 Jan;13(1):38-46. doi: 10.1016/S2213-8587(24)00276-6. Epub 2024 Nov 22. | |
| 35263518 |
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| ID | Term |
|---|---|
| D057073 | Thyrotropin Alfa |
| C000614965 | Iodine-131 |
| ID | Term |
|---|---|
| D013972 | Thyrotropin |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| I131 | Drug | An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH. |
|
| Follow up | Other |
|
|
| Rate of patients without event | at 5 years following randomization |
| Rate of events adjusted on the initial lymph node status | at 3 and 5 years following randomization |
| Recurrence rate (histologically proven) | at 3 years following randomization and then at 5 years |
| Rate of cure after an event | at 5 years after randomization |
| Cost of treatment and follow-up | at 3 years after randomization |
| Rate of events adjusted on tumoral molecular characterization | 3 and 5 years after randomization |
| Derived |
| Leboulleux S, Bournaud C, Chougnet CN, Zerdoud S, Al Ghuzlan A, Catargi B, Do Cao C, Kelly A, Barge ML, Lacroix L, Dygai I, Vera P, Rusu D, Schneegans O, Benisvy D, Klein M, Roux J, Eberle MC, Bastie D, Nascimento C, Giraudet AL, Le Moullec N, Bardet S, Drui D, Roudaut N, Godbert Y, Morel O, Drutel A, Lamartina L, Schvartz C, Velayoudom FL, Schlumberger MJ, Leenhardt L, Borget I. Thyroidectomy without Radioiodine in Patients with Low-Risk Thyroid Cancer. N Engl J Med. 2022 Mar 10;386(10):923-932. doi: 10.1056/NEJMoa2111953. |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |