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AzTrials

Thyroid CancerPhase 3ESTIMABL3NCT03570021

ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer

A Phase 3 study testing total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection and total thyroidectomy alone without neck dissection in people with Thyroid Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 21 sites in 3 countries.

Active, not recruiting

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

Official record
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Trial summary

Prospective randomized open phase III non-inferiority trial in cT1bT2N0 papillary thyroid carcinoma comparing: total thyroidectomy alone (experimental group) versus total thyroidectomy + Prophylactic Neck Dissection PND (reference group). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer
What is being tested?
total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection and total thyroidectomy alone without neck dissection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
21 sitesin 3 countries
Study dates
8 Aug 2018to Dec 2027
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

  • Thyroid nodule measuring 11-40 mm on ultrasound (cT1bT2)
  • AND with fine-needle aspiration biopsy (FNAB) cytology in favor of "papillary thyroid carcinoma" (Type 6 according to the Bethesda classification (or BRAF mutation found on cytology analysis) (Appendix 2)
  • OR with FNAB cytology "suspicious for malignancy" (Type 5 according to the Bethesda classification). In this latter case, randomization will be performed if confirmation of papillary carcinoma on intraoperative frozen section analysis
  • cN0: absence of lymph nodes suspicious for malignancy on pre- operative ultrasound performed by the center's designated radiologist according to a standardized report
  • Absence of a medical contra indication to performing a total thyroidectomy with or without bilateral prophylactic neck dissection of the central compartment
  • Women of childbearing potential should have a negative pregnancy test (serum or urine) before any radioiodine administration. Sexually active patients must agree to use an effective method of contraception or to abstain from sexual activity during the study and for at least 6 months after last dose of radioiodine.
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  • Patient affiliated to a social security regimen or beneficiary of such regimen
  • Patients age ≥ 18 years old, french-speaking
  • Patients should understand, sign and date the written informed consent form prior to any protocol specific procedures. Patients should be able and willing to comply with study visits.

Who cannot join

  • Tumors > 40 mm (cT3) or ≤ 10 mm
  • Tumors with extrathyroidal extension suspected or obvious on the pre-operative work-up or intra-operatively (cT3T4)
  • Metastatic neck lymph nodes or suspicious neck nodes on pre- operative ultrasound (cN1); for suspicious nodes, FNAB cytology and thyroglobulin assay on the needle washout fluid will be performed
  • Metastatic neck lymph nodes found during the thyroidectomy and confirmed with intra-operative frozen section analysis
  • Medullary thyroid carcinoma on FNAB cytology and/or with basal serum calcitonin >50 pg/ml
  • Preoperative or intra-operative suspicion of non-papillary thyroid carcinoma or aggressive histopathological subtype or poorly differentiated carcinoma
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  • Distant metastases (M1) apparent pre-operatively (found due to symptoms or fortuitously; no specific pre-operative work-up will be performed, however, in accordance with current clinical practice)
  • Recurrent nerve paralysis visualized on systematic pre-operative laryngoscopy and/or abnormal preoperative serum calcium
  • Pregnant or breast feeding women
  • Participation in another therapeutic clinical trial within one year from study entry
  • Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Trial locations and contacts

21 sites in 3 countries.

21 sites in 3 countries

France19 sites

  • CHU d'Angers

    Angers, 49000

  • Hôpital Saint André

    Bordeaux, 33000

  • Institut Bergonié

    Bordeaux, 33076

  • Groupement Hospitalier Est

    Bron, 69677

  • Centre François Baclesse

    Caen, 14 000

  • Jean Perrin

    Clermont-Ferrand, 63 011

  • Centre Georges François Leclerc

    Dijon, 21 079

  • CH de Haguenau

    Haguenau, 67500

  • CHU Lille, Hôpital Claude Huriez

    Lille, 59057

  • CHU Nimes

    Nîmes, 30029

  • CHU de Poitiers

    Poitiers, 86 021

  • CHU Reims - Hôpital Robert Debré

    Reims, 51 100

  • Institut Godinot

    Reims, 51 100

  • Centre Henri Becquerel

    Rouen, 76 000

  • Institut de Cancérologie Strasbourg

    Strasbourg, 67200

  • Institut Claudius Régaud

    Toulouse, 31059

  • CHU de Toulouse Hôpital Larrey

    Toulouse, 31400

  • CHRU Nancy - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 24511

  • Gustave Roussy

    Villejuif, Val de Marne, 94805

Other trials in France

Guadeloupe1 site

  • CHU de Pointe à Pitre

    Les Abymes, 97139

Other trials in Guadeloupe

Reunion1 site

  • Clinique Saint Vincent

    Réunion, 97404

Other trials in Reunion

About this study

Prospective randomized open phase III non-inferiority trial in cT1bT2N0 papillary thyroid carcinoma comparing: total thyroidectomy alone (experimental group) versus total thyroidectomy + Prophylactic Neck Dissection PND (reference group).

Pre-registered patients will be randomized before surgery for tumors with class-6 cytology (Bethesda) or in the operating room after confirmation of malignancy by frozen section analysis for tumors with class-5 cytology.

Conditions
Thyroid Cancer
Being tested
total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection, total thyroidectomy alone without neck dissection
Medical subject headings
Thyroid Neoplasms

What participants receive

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

  • total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissectionProcedure or surgery

    total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection as defined by the American Thyroid Association [American Thyroid Association Surgery Working Group, Thyroid 2009]. This is a standard treatment recognized by the French Society of Otolaryngology Head and Neck Surgery [French Society of Otolaryngology Head and Neck Sugery].

    • The number of lymph nodes resected, the number of metastatic nodes, their size and the presence or absence of extranodal spread will be recorded. Due to the large natural variability of the number of lymph nodes retrieved in a prophylactic neck dissection [Hartl DM, Ann Surg 2012], no patient will be excluded on the basis of number of lymph nodes. Furthermore, the participating surgeons routinely perform complete central neck dissections, and were chosen to participate in this study due to a homogenous technique among these surgeons [Hartl DM, World J Surg 2012].

  • total thyroidectomy alone without neck dissectionProcedure or surgery

    This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery

Study groups in NCT03570021
Study groupRoleWhat they receive
Group 1Active comparatortotal thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection as defined by the American Thyroid Association [American Thyroid Association Surgery Working Group, Thyroid 2009]. This is a standard treatment recognized by the French Society of Otolaryngology Head and Neck Surgery [French Society of Otolaryngology Head and Neck Sugery].
Receives: Procedure: total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection
Group 2Experimentaltotal thyroidectomy alone without neck dissection. This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery
Receives: Procedure: total thyroidectomy alone without neck dissection

What is being measured

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

  1. Rate of patients in complete remission

    Measured: 1 year 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 posted26 Jun 2018
  2. Study start8 Aug 2018
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two parallel groups randomized 1:1 to total thyroidectomy alone or total thyroidectomy with bilateral prophylactic central neck dissection, followed by standardized radioactive iodine ablation and scheduled follow-up assessments.
Masking
None (open label)
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03570021
Sponsor's protocol ID
2017-A01779-44
Other IDs
2017/2581
Acronym
ESTIMABL3
Status last verified
Mar 2026
First submitted
15 Jun 2018
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hartl D, Godbert Y, Carrat X, Bardet S, Lasne-Cardon A, Vera P, Ilies E, Zerdoud S, Sarini J, Zalzali M, La Manna L, Schneegans O, Kelly A, Kauffmann P, Rodien P, Brunaud L, Grunenwald S, Housseau E, Laghouati S, Bouvet N, Lecerf E, Hadoux J, Lamartina L, Schlumberger M, Borget I. ESTIMation of the ABiLity of prophylactic central compartment neck dissection to modify outcomes in low-risk differentiated thyroid cancer: a prospective randomized trial. Trials. 2023 Apr 28;24(1):298. doi: 10.1186/s13063-023-07294-0.

    PubMed 37118818

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection and total thyroidectomy alone without neck dissection in people with Thyroid Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 21 sites in 3 countries.

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 9 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France, Guadeloupe, Reunion. 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 patients in complete remission (time frame: 1 year after randomization). 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 NCT03570021, which also lists 1 linked publication.

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 6 Mar 2026.

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