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.
Male or female ≥ 18 years of age at time of diagnosis
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
Graves' disease
Symptomatic multinodular goiter
Contralateral symptomatic benign nodules
Cervical lymphadenopathy involving lateral neck or contralateral central neck
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
FDG-Positron Emission Tomography and Computed Tomography Scan
Procedure/SurgeryUndergo FDG PET/CT
Ga-68 PET/CT Scan
Procedure/SurgeryUndergo Ga-68 PET/CT
Neck Dissection
Procedure/SurgeryUndergo unilateral central neck dissection
Neck Dissection
Procedure/SurgeryUndergo contralateral neck dissection
Surveillance
BehavioralUndergo routine cancer surveillance
Thyroid Lobectomy
Procedure/SurgeryUndergo thyroid lobectomy
Thyroidectomy
Procedure/SurgeryUndergo completion thyroidectomy
Ultrasound Imaging
Procedure/SurgeryUndergo neck ultrasound
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.
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.
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.
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.
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Jonsson Comprehensive Cancer Center
Lead sponsor
Eli Lilly and Company
Collaborator
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