STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection for the Treatment of Sporadic Medullary Thyroid Cancer, STAGE-MTC Trial
Jonsson Comprehensive Cancer Center
Summary
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.
Description
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 preval…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 candidat…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureFDG-Positron Emission Tomography and Computed Tomography Scan
Undergo FDG PET/CT
- ProcedureGa-68 PET/CT Scan
Undergo Ga-68 PET/CT
- ProcedureNeck Dissection
Undergo unilateral central neck dissection
- ProcedureNeck Dissection
Undergo contralateral neck dissection
- BehavioralSurveillance
Undergo routine cancer surveillance
- ProcedureThyroid Lobectomy
Undergo thyroid lobectomy
- ProcedureThyroidectomy
Undergo completion thyroidectomy
- ProcedureUltrasound Imaging
Undergo neck ultrasound
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California