Thyroid Gland Removal with or without Central Lymph Node Dissection in Treating Patients with Node Negative Thyroid Cancer
- Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA)
- No pre-operative evidence of cervical lymph node metastases on neck ultrasound (Randomization arms ONLY)
- No evidence of distant metastases
- Ability to read and write in English
- Largest papillary thyroid carcinoma < 1 cm in size on ultrasound
- Previous thyroid surgery
- Concurrent active malignancy of another type
- Inability to give informed consent or lacks decision making capacity
- T4 tumor
- Pre-existing vocal cord paralysis
- Chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or Parkinson disease)
- Baseline laryngeal pathology that would warrant intervention that could affect voice or swallow function
- Becomes pregnant before surgery or at any time while on study
- INTRA-OPERATION EXCLUSION CRITERIA (RANDOMIZATION ARMS ONLY)
- Evidence of nodal involvement identified in the operating room (OR)
- Failure to confirm diagnosis of cancer in participant
I. To determine the rate of transient and permanent hypocalcemia.
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.
Trial Phase Phase II
Trial Type Treatment
University of Wisconsin Hospital and Clinics
Rebecca Sue Sippel
- Primary ID UW13115
- Secondary IDs NCI-2014-00833, 2014-0391
- Clinicaltrials.gov ID NCT02138214