Etude : ESTIMABL 3 /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : ESTIMABL 3

Nom :

Traitement : Chirurgie

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 07/08/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Estimation de l’impact de l’évidement ganglionnaire prophylactique du compartiment central du cou sur les résultats oncologiques des cancers différenciés de la thyroïde à bas risque de récidive loco-régionale

Spécialité : Thyroïde et autres glandes endocrines
Localisation : C73 - Tumeur maligne de la thyroïde
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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.

2 arms:
- 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].
- Experimental: Group 2
Total thyroidectomy alone without neck dissection. This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery

Phase : III

Stade : Localisé

NA
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - 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 (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 preoperative 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.

Critères de non-inclusion : - 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 preoperative 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
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03570021
Promoteur :
INSTITUT GUSTAVE ROUSSY
Type de sponsor : Institutionnel
94800 VILLEJUIF

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Stéphane BARDET

TEC / ARC / IDE :
Sophie DANET
s.danet@
baclesse.unicancer.fr

Ouverture de l'essai : OUVERT

MAJ : 07/08/2019