Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?
NCT ID: NCT01837745
Last Updated: 2023-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
776 participants
INTERVENTIONAL
2013-05-13
2030-01-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Ablation group
* Administration of 1.1 GBq of I131 is given after the second intramuscular injections of rhTSH (0.9 mg). A whole body scan (WBS) is performed 2 to 5 days after the administration or I131 with determination of the neck uptake.
* Follow-up consists in:
* 10 (+/- 2 months) after randomization: neck ultrasound + a serum Tg measurement after rhTSH stimulation
* 2 years (+/- 2 months) after randomization: serum Tg measurement under LT4 treatment (Tg/LT4)
* 3 years (+/- 2 months) after randomization: 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
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
Follow up group
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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients having undergone a total thyroidectomy with complete (R0) tumor resection, with or without lymph node neck dissection
3. Total thyroidectomy performed 2 to 5 months before inclusion
4. 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).
5. 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
6. Age \>=18 years
7. Performance status of 0 or 1
8. Patients who signed the informed consent
9. Patients who can be followed-up annually during 5 years in order to assess the objectives of the study
10. Women of childbearing age should have a negative pregnancy test before any radioiodine administration
11. Both patients with or without thyroglobulin antibodies are eligible
Exclusion Criteria
2. Patients with aggressive histotype (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing, or with an anaplastic component)
3. Patients having undergone total thyroidectomy less than 2 months or more than 5 months before inclusion
4. Patients with cancer classified as pT1a unifocal (in which ablation is not necessary), or pT1N1, pT2, pT3, pT4 or N1 (who have a higher risk of recurrence) (classification TNM 2010)
5. Patient with known distant metastasis
6. Abnormal post-operative neck ultrasound of the lateral lymph node compartments
7. Patients with another malignancy not in remission for at least 2 years (except for in situ cervix uterine cancer, basocellular skin cancer)
8. Patients with a recent history of drugs affecting thyroid function, including injection of radiocontrast agents during the last 8 weeks.
9. Patients previously treated with radioactive iodine or who previously underwent a whole body scan with radioactive iodine
10. Pregnant or breast feeding women
11. Subject with any kind of disorder that may compromise his/her ability to give written informed consent and/or to comply with study procedures
18 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Locations
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Institut Gustave Roussy
Villejuif, Val De Marne, France
Countries
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References
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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.
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.
Other Identifiers
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2012/1913
Identifier Type: OTHER
Identifier Source: secondary_id
2012-A01569-34
Identifier Type: -
Identifier Source: org_study_id
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