ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer (ESTIMABL3)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Angers, France, 49000
- CHU d'Angers
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Bordeaux, France, 33076
- Institut Bergonie
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Bordeaux, France, 33000
- Hopital Saint André
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Bron, France, 69677
- Groupement Hospitalier Est
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Caen, France, 14 000
- Centre François Baclesse
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Clermont-Ferrand, France, 63 011
- Jean Perrin
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Dijon, France, 21 079
- Centre Georges Francois Leclerc
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Haguenau, France, 67500
- CH de Haguenau
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Lille, France, 59057
- CHU Lille, Hôpital Claude Huriez
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Nîmes, France, 30029
- Chu Nimes
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Poitiers, France, 86 021
- CHU de Poitiers
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Reims, France, 51 100
- CHU Reims - Hôpital Robert Debré
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Reims, France, 51 100
- Institut Godinot
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Rouen, France, 76 000
- Centre Henri Becquerel
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Strasbourg, France, 67200
- Institut De Cancerologie Strasbourg
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Toulouse, France, 31059
- Institut Claudius Regaud
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Toulouse, France, 31400
- CHU de Toulouse Hopital Larrey
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Vandœuvre-lès-Nancy, France, 24511
- Chru Nancy - Hopitaux de Brabois
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Val de Marne
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Villejuif, Val de Marne, France, 94805
- Gustave Roussy
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Les Abymes, Guadeloupe, 97139
- CHU de Pointe à Pitre
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Réunion, Reunion, 97404
- Clinique Saint Vincent
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1
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].
|
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]. |
|
Experimental: Group 2
total thyroidectomy alone without neck dissection.
This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery
|
This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of patients in complete remission
Time Frame: 1 year after randomization
|
1 year after randomization
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-A01779-44
- 2017/2581 (Other Identifier: CSET number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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