AzTrials
AzTrials

Low Risk Differentiated Thyroid CancerPhase 3ESTIMABL2NCT01837745

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

A Phase 3 study testing rhTSH stimulation, I131 and Follow up in people with Low Risk Differentiated Thyroid Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Risk Differentiated Thyroid Cancer
What is being tested?
rhTSH stimulation, I131 and Follow up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
776 participants
Where
1 siteFrance
Study dates
13 May 2013to 1 Jan 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with differentiated thyroid cancer (papillary, follicular or with Hurthle cells) in the absence of aggressive histological subtypes (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing or with an anaplastic component)
  • Patients having undergone a total thyroidectomy with complete (R0) tumor resection, with or without lymph node neck dissection
  • Total thyroidectomy performed 2 to 5 months before inclusion
  • 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).
  • 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
  • Age >=18 years
Show all 11Show fewer
  • Performance status of 0 or 1
  • Patients who signed the informed consent
  • Patients who can be followed-up annually during 5 years in order to assess the objectives of the study
  • Women of childbearing age should have a negative pregnancy test before any radioiodine administration
  • Both patients with or without thyroglobulin antibodies are eligible

Who cannot join

  • Patients having undergone less than a total thyroidectomy
  • Patients with aggressive histotype (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing, or with an anaplastic component)
  • Patients having undergone total thyroidectomy less than 2 months or more than 5 months before inclusion
  • 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)
  • Patient with known distant metastasis
  • Abnormal post-operative neck ultrasound of the lateral lymph node compartments
Show all 11Show fewer
  • Patients with another malignancy not in remission for at least 2 years (except for in situ cervix uterine cancer, basocellular skin cancer)
  • Patients with a recent history of drugs affecting thyroid function, including injection of radiocontrast agents during the last 8 weeks.
  • Patients previously treated with radioactive iodine or who previously underwent a whole body scan with radioactive iodine
  • Pregnant or breast feeding women
  • Subject with any kind of disorder that may compromise his/her ability to give written informed consent and/or to comply with study procedures

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Gustave Roussy

    Villejuif, Val De Marne, 94805

Other trials in France

About this study

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)

Being tested
rhTSH stimulation, I131, Follow up

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhTSH stimulationDrug

    Also called Thyrogen

    Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment

  • I131Drug

    An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH.

  • Follow upOther

    • 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 groups in NCT01837745
Study groupRoleWhat they receive
Ablation groupActive comparator* 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
Receives: Drug: rhTSH stimulation; Drug: I131; Other: Follow up
Follow up groupExperimentalPatients 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.
Receives: Other: Follow up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of patient without event at 3 years following randomization

    Measured: assessed up to 3 years

Secondary outcomes (8)

  1. Lachrymal and Salivary Glands Toxicities

    Measured: Assessed up at baseline, 2 months, 10 months and 3 years after randomization

  2. Patient's quality of life, anxiety and fear of recurrence

    Measured: at inclusion, 2 months after inclusion, 10 months and 3 years after randomization

  3. Rate of patients without event

    Measured: at 5 years following randomization

  4. Rate of events adjusted on the initial lymph node status

    Measured: at 3 and 5 years following randomization

  5. Recurrence rate (histologically proven)

    Measured: at 3 years following randomization and then at 5 years

  6. Rate of cure after an event

    Measured: at 5 years after randomization

  7. Cost of treatment and follow-up

    Measured: at 3 years after randomization

  8. Rate of events adjusted on tumoral molecular characterization

    Measured: 3 and 5 years after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2013 (estimated)
  2. Study start13 May 2013
  3. Primary completion1 Apr 2022
  4. Study completion1 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
776 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01837745
Sponsor's protocol ID
2012-A01569-34
Other IDs
2012/1913
Acronym
ESTIMABL2
Status last verified
May 2023
First submitted
16 Apr 2013
Last updated
17 May 2023
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39586309

  • 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.

    PubMed 35263518

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhTSH stimulation, I131 and Follow up in people with Low Risk Differentiated Thyroid Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of patient without event at 3 years following randomization (time frame: assessed up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01837745, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in