Evaluating the impact of neck dissection during thyroid cancer surgery
ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer
This study is testing if adding neck surgery to thyroid cancer treatment helps people with low-risk thyroid cancer do better without causing extra problems.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris Academic / other |
| Locations | 1 site (Villejuif, Val De Marne) |
| Trial ID | NCT03570021 on ClinicalTrials.gov |
What this trial studies
This phase III trial investigates the effectiveness of adding prophylactic central compartment neck dissection to total thyroidectomy in patients with low-risk differentiated thyroid cancer. Participants will be randomly assigned to receive either total thyroidectomy alone or total thyroidectomy with neck dissection. The study aims to determine if the additional neck dissection improves patient outcomes without compromising safety. Patients will be pre-registered and randomized based on specific cytology results from fine-needle aspiration biopsies.
Who should consider this trial
Good fit: Ideal candidates are patients with cT1bT2N0 papillary thyroid carcinoma who meet specific cytology criteria.
Not a fit: Patients with thyroid cancer that does not meet the inclusion criteria or those with contraindications for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients with low-risk thyroid cancer.
How similar studies have performed: Previous studies have explored similar surgical approaches, but this specific combination of interventions is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Villejuif, Val De Marne
- Gustave Roussy — Villejuif, Val De Marne, France (Recruiting)
Study contacts
- Study coordinator: Dana HARTL, MD,PhD
- Email: dana.hartl@gustaveroussy.fr
- Phone: +33 (0)1 42 11 46 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.