STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Biospecimen Collection
  Undergo blood sample collection
• Процедура FDG-Positron Emission Tomography and Computed Tomography Scan
  Undergo FDG PET/CT
• Процедура Ga-68 PET/CT Scan
  Undergo Ga-68 PET/CT
• Процедура Neck Dissection
  Undergo unilateral central neck dissection
• Процедура Neck Dissection
  Undergo contralateral neck dissection
• Поведенческое Surveillance
  Undergo routine cancer surveillance
• Процедура Thyroid Lobectomy
  Undergo thyroid lobectomy
• Процедура Thyroidectomy
  Undergo completion thyroidectomy
• Процедура Ultrasound Imaging
  Undergo neck ultrasound

Первичные конечные точки

• Proportion of patients who achieve biochemical remission [Срок оценки: Up to 3 months]
• Proportion of patients requiring completion thyroidectomy [Срок оценки: Up to 12 months]

Вторичные конечные точки (2)

• Short-term oncologic outcomes [Срок оценки: At 12 months]
• Prevalence of occult contralateral disease [Срок оценки: Perioperative/Periprocedural]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Идентификаторы

NCT: NCT07612293 · 25-0553 · NCI-2026-03211

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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