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STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection

2026年5月27日 更新者：Jonsson Comprehensive Cancer Center

STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection for the Treatment of Sporadic Medullary Thyroid Cancer, STAGE-MTC Trial

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

OUTLINE:

Patients undergo thyroid lobectomy with unilateral central neck dissection on study. Patients then undergo blood sample collection for calcitonin and carcinoembryonic antigen (CEA) monitoring with neck ultrasound and/or gallium-68 (Ga-68) or fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) at 3 and 6 month follow-ups. Patients with no biochemical or imaging evidence of persistent disease undergo routine cancer surveillance. Patients with either of the following: 1) Elevated or rising calcitonin and/or CEA plus imaging suggestive of residual disease in the contralateral thyroid lobe or contralateral cervical lymph nodes, or 2) Elevated or rising calcitonin and/or CEA with negative imaging for an alternate source, consistent with biochemical evidence of residual disease in the remaining thyroid lobe, may undergo completion thyroidectomy and/or contralateral neck dissection during follow up. Patients also undergo additional blood sample collection, neck ultrasound, and/or Ga-68 or FDG PET/CT throughout the study.

After completion of study intervention, patients are followed up at day 14 and months 3, 6, 12, 18, and 24.

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • California
      • Los Angeles、California、美国、90095
        • UCLA / Jonsson Comprehensive Cancer Center
        • 首席研究员：
          • James Wu, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Treatment (thyroid lobectomy, unilateral neck dissection)
Patients undergo thyroid lobectomy with unilateral central neck dissection on study. Patients then undergo blood sample collection for calcitonin and CEA monitoring with neck ultrasound and/or Ga-68 or FDG PET/CT at 3 and 6 month follow-ups. Patients with no biochemical or imaging evidence of persistent disease undergo routine cancer surveillance. Patients with either of the following: 1) Elevated or rising calcitonin and/or CEA plus imaging suggestive of residual disease in the contralateral thyroid lobe or contralateral cervical lymph nodes, or 2) Elevated or rising calcitonin and/or CEA with negative imaging for an alternate source, consistent with biochemical evidence of residual disease in the remaining thyroid lobe, may undergo completion thyroidectomy and/or contralateral neck dissection during follow up. Patients also undergo additional blood sample collection, neck ultrasound, and/or Ga-68 or FDG PET/CT throughout the study.
程序：生物样本采集
进行血液样本采集
其他名称：
  • 生物样本采集
  • 收集的生物样本
  • 标本采集
  • 样本收集
程序：超声成像
接受颈部超声检查
其他名称：
  • 超音波
  • 二维灰度超声成像
  • 二维超声成像
  • 二维美国
  • 超声波测试
  • 超声波，医疗
  • 我们
  • 超声检查
程序：FDG-Positron Emission Tomography and Computed Tomography Scan
Undergo FDG PET/CT
其他名称：
  • 葡萄糖PET/CT
程序：Ga-68 PET/CT Scan
Undergo Ga-68 PET/CT
其他名称：
  • Gallium-68 PET/CT Scan
  • Gallium-68 Positron Emission Tomography and Computed Tomography Scan
程序：Neck Dissection
Undergo unilateral central neck dissection
程序：Neck Dissection
Undergo contralateral neck dissection
行为的：Surveillance
Undergo routine cancer surveillance
其他名称：
  • 流行病学/监测
程序：Thyroid Lobectomy
Undergo thyroid lobectomy
其他名称：
  • Lobectomy of Thyroid Gland
  • Unilateral Thyroid Lobectomy
程序：Thyroidectomy
Undergo completion thyroidectomy

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of patients who achieve biochemical remission
大体时间：Up to 3 months
Will calculate the proportion of patients who achieve biochemical remission at 3 months (normal calcitonin and carcinoembryonic antigen [CEA]). Exact 95% confidence intervals will be provided. Exploratory subgroup analyses (e.g., stratified by baseline calcitonin level, tumor size, or nodal status) may be conducted to generate hypotheses but will not be powered for formal inference.
Up to 3 months
Proportion of patients requiring completion thyroidectomy
大体时间：Up to 12 months
Completion thyroidectomy will be indicated in the setting of: Elevated or rising calcitonin and/or CEA plus imaging (neck ultrasound or positron emission tomography [PET]/computed tomography [CT]) suggestive of residual disease in the contralateral thyroid lobe or contralateral cervical lymph nodes; or elevated or rising calcitonin and/or CEA with negative neck ultrasound and PET/CT for an alternate source, consistent with biochemical evidence of residual disease in the remaining thyroid lobe. Exact 95% confidence intervals will be provided. Exploratory subgroup analyses (e.g., stratified by baseline calcitonin level, tumor size, or nodal status) may be conducted to generate hypotheses but will not be powered for formal inference.
Up to 12 months

次要结果测量

结果测量
措施说明
大体时间
Short-term oncologic outcomes
大体时间：At 12 months
Short-term oncologic outcomes will be categorized according to the American Thyroid Association ATA) "response to therapy" framework, adapted for medullary thyroid carcinoma. Categories will include: Excellent response: Normal calcitonin and CEA with no structural evidence of disease on imaging; Biochemical incomplete response: Abnormal calcitonin and/or CEA without structural evidence of disease; Structural incomplete response: Evidence of structural disease on imaging, regardless of biochemical status. Will be summarized descriptively. Exact 95% confidence intervals will be reported. Comparisons to baseline disease features (e.g., initial calcitonin levels, tumor size, lymph node involvement) may be explored but will be considered hypothesis-generating only.
At 12 months
Prevalence of occult contralateral disease
大体时间：Perioperative/Periprocedural
Among patients who undergo completion thyroidectomy and/or contralateral neck dissection, will assess the prevalence of previously undetected foci of medullary thyroid cancer in the contralateral thyroid lobe and contralateral cervical lymph nodes. Pathologic findings will be reported as proportions with corresponding exact 95% confidence intervals.
Perioperative/Periprocedural

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Jonsson Comprehensive Cancer Center

合作者

Eli Lilly and Company

调查人员

  • 首席研究员：James Wu, MD、UCLA / Jonsson Comprehensive Cancer Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月2日

初级完成 (估计的)

2031年9月2日

研究完成 (估计的)

2032年4月21日

研究注册日期

首次提交

2026年5月18日

首先提交符合 QC 标准的

2026年5月27日

首次发布 (实际的)

2026年5月28日

研究记录更新

最后更新发布 (实际的)

2026年5月28日

上次提交的符合 QC 标准的更新

2026年5月27日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 25-0553
  • NCI-2026-03211 (注册表标识符：CTRP (Clinical Trial Reporting Program))

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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