STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection for the Treatment of Sporadic Medullary Thyroid Cancer, STAGE-MTC Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This clinical trial studies how well thyroid lobectomy with ipsilateral central neck dissection works to treat medullary thyroid cancer (MTC) in patients without a germline RET mutation (sporadic). Currently, sporadic and germline RET (rearranged during transfection) mutation positive MTCs that are limited to the thyroid are managed in the same way, complete surgical removal of the entire thyroid gland (total thyroidectomy) with surgical removal of lymph nodes and other tissues on both sides of the neck (bilateral central neck dissection). Total thyroidectomy and bilateral central neck dissection carry a high risk of complications, and total thyroidectomy requires patients to take lifelong thyroid hormone replacement therapy, which can impact quality of life. Research has shown that patients with sporadic MTC do not have a high risk of developing MTC in the remaining normal thyroid tissue and that they may be able to be managed differently than patients with germline RET mutations. Thyroid lobectomy with ipsilateral central neck dissection is a surgical procedure which removes only the lobe of the thyroid gland that is affected by cancer as well as the lymph nodes and other tissues from the affected side of the neck. Thyroid lobectomy with ipsilateral central neck dissection may be a safer, more tolerable, and/or more effective way to treat sporadic MTC.
详细描述
PRIMARY OBJECTIVE:
I. To determine the number of patients that have no biochemical evidence of persistent medullary thyroid cancer following thyroid lobectomy and ipsilateral prophylactic central neck dissection alone versus number of patients with biochemical evidence of persistent MTC that requires completion thyroidectomy.
SECONDARY OBJECTIVES:
I. Determine the short-term oncologic treatment outcomes of a novel staged approach to sporadic medullary thyroid cancer, defined by response to therapy category (excellent, biochemical incomplete, structural incomplete).
II. Determine the prevalence of undetected foci of medullary thyroid cancer in contralateral thyroid lobe and contralateral lymph nodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female ≥ 18 years of age at time of diagnosis
- •Documentation of a medullary thyroid cancer diagnosis as evidenced by:
- •Thyroid fine needle aspiration biopsy with cytologist consistent with medullary thyroid cancer
- •Indeterminate cytology from thyroid fine needle aspiration with elevated serum calcitonin OR thyroid molecular testing consistent with medullary thyroid cancer
- •Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
- •Appropriate candidate for thyroid lobectomy and/or total thyroidectomy
排除标准
- •Indication for total thyroidectomy unrelated to medullary thyroid cancer:
- •Graves' disease
- •Symptomatic multinodular goiter
- •Contralateral symptomatic benign nodules
- •Ultrasound findings consistent with:
- •Cervical lymphadenopathy involving lateral neck or contralateral central neck
- •Suspicious thyroid nodules > 1 cm that are Thyroid Imaging Reporting and Data Systems 2 (TIRADS2) or higher without fine needle aspiration (FNA)
- •Pure cystic and spongiform nodules do not require FNA
- •Patients with nodules that meet criteria above can elect to undergo FNA, and may enroll in study if benign cytology is noted
- •Identification of germline RET mutation on preoperative genetic testing