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Less surgery may be enough for Low-Risk thyroid cancer

NCT ID NCT03570021

Disease control Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether removing only the thyroid gland works as well as also removing nearby lymph nodes in people with low-risk thyroid cancer. About 352 patients with small to medium-sized tumors will be randomly assigned to one of the two surgeries. The goal is to see if the simpler surgery leads to the same rate of complete remission, potentially avoiding extra side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

352 people

The number who actually took part.

Started

Aug 2018

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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 2. cN0: absence of lymph nodes suspicious for malignancy on pre- operative ultrasound performed by the center's designated radiologist according to a standardized report 3. Absence of a medical contra indication to performing a total thyroidectomy with or without bilateral prophylactic neck dissection of the central compartment 4. 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. 5. Patient affiliated to a social security regimen or beneficiary of such regimen 6. Patients age ≥ 18 years old, french-speaking 7. 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. Exclusion Criteria: 1. Tumors \> 40 mm (cT3) or ≤ 10 mm 2. Tumors with extrathyroidal extension suspected or obvious on the pre-operative work-up or intra-operatively (cT3T4) 3. 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 4. Metastatic neck lymph nodes found during the thyroidectomy and confirmed with intra-operative frozen section analysis 5. Medullary thyroid carcinoma on FNAB cytology and/or with basal serum calcitonin \>50 pg/ml 6. Preoperative or intra-operative suspicion of non-papillary thyroid carcinoma or aggressive histopathological subtype or poorly differentiated carcinoma 7. 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) 8. Recurrent nerve paralysis visualized on systematic pre-operative laryngoscopy and/or abnormal preoperative serum calcium 9. Pregnant or breast feeding women 10. Participation in another therapeutic clinical trial within one year from study entry 11. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

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Conditions

The condition(s) this trial relates to.

thyroid cancer thyroid gland papillary carcinoma Thyroid Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thyroid cancer

Contacts and locations

Locations

  • CH de Haguenau

    Haguenau, 67500, France

  • CHRU Nancy - Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 24511, France

  • CHU Lille, Hôpital Claude Huriez

    Lille, 59057, France

  • CHU Nimes

    Nîmes, 30029, France

  • CHU Reims - Hôpital Robert Debré

    Reims, 51 100, France

  • CHU d'Angers

    Angers, 49000, France

  • CHU de Pointe à Pitre

    Les Abymes, 97139, Guadeloupe

  • CHU de Poitiers

    Poitiers, 86 021, France

  • CHU de Toulouse Hôpital Larrey

    Toulouse, 31400, France

  • Centre François Baclesse

    Caen, 14 000, France

  • Centre Georges François Leclerc

    Dijon, 21 079, France

  • Centre Henri Becquerel

    Rouen, 76 000, France

  • Clinique Saint Vincent

    Réunion, 97404, Reunion

  • Groupement Hospitalier Est

    Bron, 69677, France

  • Gustave Roussy

    Villejuif, Val de Marne, 94805, France

  • Hôpital Saint André

    Bordeaux, 33000, France

  • Institut Bergonié

    Bordeaux, 33076, France

  • Institut Claudius Régaud

    Toulouse, 31059, France

  • Institut Godinot

    Reims, 51 100, France

  • Institut de Cancérologie Strasbourg

    Strasbourg, 67200, France

  • Jean Perrin

    Clermont-Ferrand, 63 011, France

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