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

NCT03570021 | Active Not Recruiting Phase 3

• 2 other identifiers: 2017-A01779-442017/2581
• Study Type: interventional
• Target: 352
• Locations: 3 countries
• Sites: 21

Brief 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.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of patients in complete remission

  1 year after randomization

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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 \[French Society of Otolaryngology Head and Neck Sugery\].

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

Group 2

EXPERIMENTAL

total thyroidectomy alone without neck dissection. This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery

Procedure: total thyroidectomy alone without neck dissection

Interventions

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

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 \[Hartl DM, World J Surg 2012\].

Group 1

total thyroidectomy alone without neck dissection PROCEDURE

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (21)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

CHU d'Angers

Angers, 49000, France

Location

Hôpital Saint André

Bordeaux, 33000, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Groupement Hospitalier Est

Bron, 69677, France

Location

Centre François Baclesse

Caen, 14 000, France

Location

Jean Perrin

Clermont-Ferrand, 63 011, France

Location

Centre Georges François Leclerc

Dijon, 21 079, France

Location

CH de Haguenau

Haguenau, 67500, France

Location

CHU Lille, Hôpital Claude Huriez

Lille, 59057, France

Location

CHU Nimes

Nîmes, 30029, France

Location

CHU de Poitiers

Poitiers, 86 021, France

Location

CHU Reims - Hôpital Robert Debré

Reims, 51 100, France

Location

Institut Godinot

Reims, 51 100, France

Location

Centre Henri Becquerel

Rouen, 76 000, France

Location

Institut de Cancérologie Strasbourg

Strasbourg, 67200, France

Location

Institut Claudius Régaud

Toulouse, 31059, France

Location

CHU de Toulouse Hôpital Larrey

Toulouse, 31400, France

Location

CHRU Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, 24511, France

Location

CHU de Pointe à Pitre

Les Abymes, 97139, Guadeloupe

Location

Clinique Saint Vincent

Réunion, 97404, Reunion

Location

Related Publications (1)

• 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.

  PMID: 37118818 DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Neck Dissection

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Lymph Node Excision; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 26, 2018
• Study Start: August 8, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

FR (19); GU (1); RE (1)