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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-03211 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (thyroid lobectomy, unilateral neck dissection) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who achieve biochemical remission | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term oncologic outcomes | 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. |
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Inclusion Criteria:
Male or female ≥ 18 years of age at time of diagnosis
Documentation of a medullary thyroid cancer diagnosis as evidenced by:
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:
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)
Identification of germline RET mutation on preoperative genetic testing
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Hughes | Contact | 310 206-9145 | EGHughes@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| James Wu, MD | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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| FDG-Positron Emission Tomography and Computed Tomography Scan | Procedure | Undergo FDG PET/CT |
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| Ga-68 PET/CT Scan | Procedure | Undergo Ga-68 PET/CT |
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| Neck Dissection | Procedure | Undergo unilateral central neck dissection |
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| Neck Dissection | Procedure | Undergo contralateral neck dissection |
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| Surveillance | Behavioral | Undergo routine cancer surveillance |
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| Thyroid Lobectomy | Procedure | Undergo thyroid lobectomy |
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| Thyroidectomy | Procedure | Undergo completion thyroidectomy |
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| Ultrasound Imaging | Procedure | Undergo neck ultrasound |
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| At 12 months |
| Prevalence of occult contralateral disease | 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 |
| ID | Term |
|---|---|
| D018276 | Carcinoma, Medullary |
| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D037981 | Neck Dissection |
| D013965 | Thyroidectomy |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D008197 | Lymph Node Excision |
| D013514 | Surgical Procedures, Operative |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013507 | Endocrine Surgical Procedures |
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
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