ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer (ESTIMABL3)

Gustave Roussy

Status and phase: Enrolling; Phase 3

Conditions: Thyroid Cancer

Treatments: Procedure: total thyroidectomy alone without neck dissection; Procedure: total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT03570021

2017-A01779-44

2017/2581 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 (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 preoperative 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 preoperative 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Group 1

Active Comparator group

Description:

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

Treatment:

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

Group 2

Experimental group

Description:

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

Treatment:

Procedure: total thyroidectomy alone without neck dissection