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ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

NCT03570021•Gustave Roussy, Cancer Campus, Grand Paris

View on ClinicalTrials.gov

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). 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (21)

Gustave Roussy

Villejuif, Val de Marne, France

CHU d'Angers

Angers, France

Hôpital Saint André

Bordeaux, France

Institut Bergonié

Bordeaux, France

Groupement Hospitalier Est

Bron, France

Centre François Baclesse

Caen, France

Jean Perrin

Clermont-Ferrand, France

Centre Georges François Leclerc

Dijon, France

CH de Haguenau

Haguenau, France

CHU Lille, Hôpital Claude Huriez

Lille, France

Key Dates

Start Date

August 8, 2018

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2027

Last Updated

March 6, 2026

Enrollment

352

ACTUAL participants

Conditions

Thyroid Cancer

Interventions

total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection

PROCEDURE

total thyroidectomy alone without neck dissection

PROCEDURE

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

NCT06316895

Papillary Thyroid Cancer

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RECRUITINGPHASE2

Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

NCT07092514

Thyroid CancerCancer of the Thyroid

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma

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