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

Launched by GUSTAVE ROUSSY, CANCER CAMPUS, GRAND PARIS · Jun 15, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding a specific surgical procedure called Prophylactic Neck Dissection (PND) to the standard treatment of total thyroidectomy (removal of the thyroid gland) can improve outcomes for patients with low-risk papillary thyroid cancer. The study aims to see if performing PND, which involves removing some lymph nodes in the neck, affects the health of patients compared to those who only have the thyroid removed. It is a Phase 3 trial, which means it's testing the effectiveness of this approach in a larger group of people.

To participate in this trial, you need to be at least 18 years old, speak French, and have a thyroid nodule that is between 11 to 40 mm with test results indicating a likely papillary thyroid cancer. You should also not have any suspicious lymph nodes in your neck and must be in good health to undergo surgery. If you decide to join, you will be randomly assigned to one of the two treatment groups before your surgery. The trial is currently recruiting participants, and anyone considering joining should be prepared to sign a consent form and attend follow-up visits. This study will help doctors understand the best approach for treating this type of cancer and could improve care for future patients.

Gender

ALL

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