This randomized phase II trial studies how well thyroid gland removal with or without central lymph node dissection works in treating patients with thyroid cancer or suspected thyroid cancer that has not spread to the lymph nodes. Currently, the standard treatment for thyroid cancer is total thyroidectomy, or complete removal of the thyroid. Sometimes, the lymph nodes in the central part of the neck may also be surgically removed, called central lymph node dissection. Prophylactic removal of the lymph nodes may increase the risk of life-threatening complications, and may reduce post-surgery quality of life. It may also reduce the chance of cancer returning and the need for additional surgery. It is not yet known whether recurrence rates and complication levels are lower after thyroid gland removal alone or with central lymph node dissection.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02138214.
PRIMARY OBJECTIVES:
I. To determine the rate of transient and permanent hypocalcemia.
SECONDARY OBJECTIVES:
I. To determine the rate of voice and swallowing problems.
II. To determine the degree to which quality of life (QOL) is compromised.
III. To determine whether accurate quality of life measures can be extracted from patient interview narratives.
IV. To determine clinical recurrence rates, measures of thyroglobulin levels, and clinical evidence of recurrent disease.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. Patients who are not receiving total thyroidectomies eligible for the randomization arms pre-operatively or are unable to be randomized intraoperatively are assigned to Arm III.
ARM I: Patients undergo total thyroidectomy alone.
ARM II: Patients undergo total thyroidectomy with ipsilateral prophylactic central neck dissection (CND).
ARM III: Patients undergo standard of care.
After completion of study treatment, patients are followed up at days 1 and 12, at 6 weeks, and at 6 and 12 months.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorRebecca Sue Sippel
