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

NCT ID: NCT03570021

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2029-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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 2

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

Group Type: EXPERIMENTAL

total thyroidectomy alone without neck dissection

Intervention Type: PROCEDURE

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

Interventions

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

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].

Intervention Type: PROCEDURE

total thyroidectomy alone without neck dissection

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gustave Roussy

Villejuif, Val De Marne, France

Site Status: RECRUITING

Countries

France

Central Contacts

Dana HARTL, MD,PhD

Role: CONTACT

dana.hartl@gustaveroussy.fr

+33 (0)1 42 11 46 12

Facility Contacts

Dana HARTL, MD,PhD

Role: primary

dana.hartl@gustaveroussy.fr

+33 (0)1 42 11 46 12

References

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.

Reference Type: DERIVED

PMID: 37118818 (View on PubMed)

Other Identifiers

2017/2581

Identifier Type: OTHER

Identifier Source: secondary_id

2017-A01779-44

Identifier Type: -

Identifier Source: org_study_id