ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 352
- 试验地点
- 21
- 主要终点
- Rate of patients in complete remission
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 (or BRAF mutation found on cytology analysis) (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 pre- operative 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.
排除标准
- •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 pre- operative 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
研究组 & 干预措施
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].
干预措施: total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection (Procedure)
Group 2
total thyroidectomy alone without neck dissection. This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery
干预措施: total thyroidectomy alone without neck dissection (Procedure)
结局指标
主要结局
Rate of patients in complete remission
时间窗: 1 year after randomization
次要结局
未报告次要终点